System, image processing, radiological

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BOSTON SCIENTIFIC (BSC). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. ADDITIONALLY, DETAILED DESCRIPTION OF THE EVENT AND PRODUCT RETURN STATUS WERE NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE RUPTURE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN UNKNOWN BOSTON SCIENTIFIC DEVICE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.