BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA¿

    MDR report key: 2872389 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07767
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    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: 18 YEARS OR OLDER. (B)(4). 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

    SAME CASE AS MDR ID# 2134265-2012-07819. SAME CASE AS MDR ID# 2134265-2012-07768. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY USING A 7F 25 CM NON BSC INTRODUCER SHEATH. A .035 GUIDE WIRE SUCCESSFULLY CROSSED THE TARGET LESION. FOR PREDILATION A 8.0 X 20, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION AT 10 ATMS A BALLOON RUPTURE OCCURRED. THE MUSTANG BALLOON CATHETER WAS REMOVED INTACT. A 8.0-40, 135 WANDA BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND DILATION WAS PERFORMED. AN EXPRESS VASCULAR LD STENT WAS DEPLOYED AT THE TARGET LESION, HOWEVER DUE TO THE DEGREE OF VESSEL CALCIFICATION, THE STENT DID NOT FULLY APPOSE TO THE VESSEL WALL BUT REMAINED IN POSITION. THE SDS WAS REMOVED AND THE STENT WAS DILATED WITH THE 8.0-40, 135 WANDA BALLOON CATHETER. DURING THE FIRST INFLATION AT 12 ATMS A BALLOON RUPTURE OCCURRED. THE WANDA BALLOON CATHETER WAS REMOVED INTACT AND THE STENT WAS SUCCESSFULLY DEPLOYED WITH A 8-40 MM MUSTANG BALLOON CATHETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE. 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¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505400 14846810

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 035 RADIFOCUS| BALLOON CATHETER: 8.0 X 20, 75 CM MUSTANG| STENT: 8-57 MM EXPRESS VASCULAR LD| INTRODUCER SHEATH: 7F 25 CM ZEON| BALLOON CATHETER: 8 X 40 MM WANDA