EMAIL TO A FRIEND COMMENT

 

Vascular Sheath Shaft May Fragment; Emboli, Stroke, Injuries


Boston Scientific has voluntarily recalled the Chariot Guiding Sheath globally. These devices are intended for the introduction of interventional devices during peripheral vascular procedures, and were recalled on November 19th due to the risk of shaft separation. This Class 1 recall affects all UPNs of the Chariot Guiding Sheaths. The Chariot is considered a “guiding sheath” because it is inserted in a patient’s blood vessels so that other, thinner tools can slide through it and be easily directed to disease sites.

 

To date, Boston Scientific has received fourteen complaints of shaft separation, including four cases where the separation happened on the end inserted into the patient’s body. These events occurred during device preparation or use. The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs. No permanent injuries or patient deaths have been reported.

 

All affected healthcare facilities were previously advised to immediately discontinue use of affected devices and return unused Chariot Guiding Sheaths to Boston Scientific. The company says doctors who used the Chariot sheath for minimally invasive procedures in the legs and arms should check back with those patients to confirm their post-procedure status, as device shaft separation and embolized fragments may not have been recognized at the time of the procedure.

 

The device is relatively new to the market. The FDA gave Boston Scientific clearance to sell the Chariot Guiding Sheath on June 5, 2015, according to FDA records. It was supposed to be substantially equivalent to an earlier model, the Terumo Pinnacle Destination sheath, approved in 2009.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease

 

See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks

 

See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death

 

See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues 

 

 

REPRINTS & PERMISSIONS COMMENT