BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA PTA BALLOON DILATATION CATHETER

    MDR report key: 1968438 · Received January 24, 2011

    Report

    Report Number
    2134265-2011-00055
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    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: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. A 4 FR J INTRODUCER SHEATH WAS INSERTED INFO THE RIGHT FEMORAL ARTERY AND A 4 FR 10CM INTRODUCER SHEATH WAS INSERTED INTO THE LEFT FEMORAL TO OBTAIN VASCULAR ACCESS. A NON-BSC GUIDE WIRE WAS ADVANCED AND A 4.0MM X 40MM STERLING BALLOON CATHETER WAS USED TO PREDILATE THE LESION. A 7MM X 57MM EXPRESS LD AND AN 8MM X 38MM WERE IMPLANTED IN THE LESION. A 5.0MM X 40MM WANDA BALLOON CATHETER WAS USED FOR POST-DILATION. ADDITIONAL POST DILATION WAS REQUIRED SO THE 7.0MM X 20MM WANDA BALLOON CATHETER WAS ADVANCED, INFLATED ONE TIME TO 7 ATMS AND RUPTURED. ONCE THE 7.0MM X 20MM WANDA WAS REMOVED FROM THE PATIENT A PINHOLE WAS NOTED IN THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WANDA PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505120 0012359744

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO 6F 10CM| INTRODUCER SHEATH: MEDKIT 4FR J| BALLOON CATHETER: STERLING OTW 4-40/80| GUIDE WIRE: ASTATO| STENT: EXPRESS LD 7-57| INFLATION DEVICE: JMS| GUIDE WIRE: RADIOFOCUS .035| BALLOON CATHETER: STERLING 4MM X 40MM| STENT: WALLSTENT 8-38| INTRODUCER SHEATH: ZEON 4F 10CM| GUIDE WIRE: TREASURE