BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 3526293 · Received December 18, 2013

    Report

    Report Number
    2134265-2013-09248
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 4, 2013
    Report Date
    November 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MFR: 2134265-2013-09247. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, STENT DAMAGE, A STENT FRACTURE AND A THROMBOSIS OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WITH AN EJECTION FRACTION OF 40% WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 20 X 4.00 PROMUS PREMIER STENT WAS SELECTED AND WAS DEPLOYED IN THE MID RCA. THE STENT REMAINED UNEXPANDED IN THE DISTAL LOCATION DUE TO THE DIFFERENCE IN THE VESSEL DIAMETER BETWEEN THE PROXIMAL AND THE DISTAL PART OF THE LESION. A 5X10MM NC QUANTUM APEX BALLOON CATHETER WAS USED TO POST DILATE THE UNEXPANDED PORTION OF THE STENT, WHEN THE BALLOON WAS DEFLATED THE STENT APPEARED TO BE DAMAGED AND BROKEN IN A WEAK PART OF THE CONNECTOR. THE PATIENT SUFFERED A SUDDEN THROMBUS FORMATION IN THE DAMAGED PORTION OF THE STENT DURING THE INFLATION OF THE DIFFERENT BALLOON CATHETERS. THE PATIENT WAS TREATED THROUGH ANTI THROMBOLYTIC THERAPY (REO PRO). THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED TWO DAYS LATER AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661893 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention