BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1771707 · Received July 28, 2010

    Report

    Report Number
    2134265-2010-03200
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH A BLOOD-LIKE SUBSTANCE IN THE SHAFT AND BALLOON. THE BALLOON WAS RETURNED IN A DEFLATED STATE. MAGNIFIED AND TACTILE INSPECTION OF THE BALLOON REVEALED A SCRATCH MEASURING APPROXIMATELY 4MM. EXAMINATION OF THE MATERIAL SURROUNDING THE SCRATCH DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE INCIDENT. MICROSCOPIC INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION PROCEDURE (PPI), A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED AT THE CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY (ATA). UPON THE FIRST INFLATION OF A 2MM X 20MM X 143CM STERLING ES PTA BALLOON DILATATION CATHETER A BALLOON RUPTURE OCCURRED AT 10ATMS. THE INFLATION DURATION IS UNKNOWN. THE BALLOON CATHETER WAS SUCCESSFULLY REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A STERLING ES 2 X 40MM BALLOON CATHETER. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135202010 13338633

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: ENCORE| GW: TRESURE XS, CRUISE| INTRODUCER SHEATH: 4.5F PARENT