BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARGER¿

    MDR report key: 2982694 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01060
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K110122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    SAME CASE AS MDR ID# 2134265-2013-01059, 2134265-2013-01058, 2134265-2013-01061. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE ENTRAPMENT OCCURRED. A 45CM, 6F NON BSC SHEATH WAS USED TO OBTAIN VASCULAR ACCESS. THE TARGET LESION WAS LOCATED IN THE HEAVILY DISEASED, MODERATE-SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 300CM V-18 CONTROL WIRE WAS PLACED AT THE TARGET LESION. AN EPIC STENT WAS SUCCESSFULLY IMPLANTED AT THE LEFT SFA. FOR POST DILATION A 5.0 X 100/135 STERLING BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION, AND AFTER SEVERAL INFLATIONS AT APPROXIMATELY 9-10ATMS, A BALLOON RUPTURE OCCURRED. THE EPIC STENT REMAINED WELL POSITIONED AND APPOSED TO THE VESSEL WALL. FOR ADDITIONAL POST DILATION A 6.0 X 100/135 STERLING OTW BALLOON CATHETER WAS ADVANCED TO THE IMPLANTED EPIC STENT AND SEVERAL INFLATIONS WERE SUCCESSFULLY PERFORMED. NEXT, THE STERLING OTW BALLOON CATHETER WAS MOVED TO THE LEFT EXTERNAL ILIAC ARTERY TO AN APPROXIMATELY %70 STENOSED, VERY SMALL, TIGHT, FOCAL LESION. AFTER APPROXIMATELY 8 INFLATIONS AT 9-10ATMS, A BALLOON RUPTURE OCCURRED AT 10ATMS. THE STERLING OTW BALLOON CATHETER WAS REMOVED INTACT. A 7.0 X40, 135CM CHARGER BALLOON CATHETER WAS ADVANCED TO THE LEFT EXTERNAL ILIAC ARTERY AND WAS SUCCESSFULLY INFLATED. DURING WITHDRAWAL OF THE V-18 CONTROL WIRE, THE DEVICE BECAME STUCK RIGHT AROUND THE MID PORTION OF THE CHARGER BALLOON CATHETER WHICH CAUSED THE CATHETER TO BUCKLE AND MISSHAPE. THE PHYSICIAN PUSHED AND PULLED THE WIRE SEVERAL TIMES BUT WAS UNABLE TO REMOVE THE WIRE, AS A RESULT THE V-18 GUIDE WIRE AND THE CHARGER BALLOON CATHETER WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED AND NO FURTHER ACTIONS WERE PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88370 CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939206070410 0015723010

    Patients

    Seq Age Sex Outcome Treatment
    1 INTODUCER SHEATH, 45CM, 6F COOK ANSEL| BALLOON CATHETER, 6.0 X 100/135| STENT, EPIC| GUIDE WIRE, V-18, 300CM, 8CM| BALLOON CATHETER, 5.0 X 100/135 STERLING