BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1821010 · Received August 31, 2010

    Report

    Report Number
    2134265-2010-03844
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    April 12, 2010
    Report Date
    August 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (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

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-03800, 2134265-2010-03801, 2134265-2010-03840, 2134265-2010-03841, 2134265-2010-03842. SAME PATIENT AS MFR REPORT #: 2134265-2010-03962, 2134265-2010-03963. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A BALLOON PIN HOLE LEAK OCCURRED. THE INDEX PROCEDURE TREATED THE 90% STENOSED, 3.5X50MM TARGET LESION LOCATED IN THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). TREATMENT CONSISTED OF PRE-DILATION USING A 3.0 X 20MM APEX BALLOON. THREE OVERLAPPING INFLATIONS WERE MADE AT 16, 18, AND 18 ATMS' FOR A MAXIMUM OF 43 SECONDS. THE BALLOON THEN DEVELOPED A PINHOLE LEAK AND WAS REMOVED. NEXT A 3.50 X 38MM TAXUS LIBERTÉ STENT WAS PLACED. POST-DILATATION WAS PERFORMED WITH A 4.0 X 20MM QUANTUM BALLOON AT 22 AND 24 ATM'S. THIS BALLOON ALSO DEVELOPED A PINHOLE LEAK AND WAS REMOVED. A SECOND 4.0 X 20MM QUANTUM BALLOON WAS USED TO POST-DILATE THE PREVIOUSLY PLACED STENT USING OVERLAPPING INFLATIONS AT 24 ATM'S. THIS BALLOON ALSO DEVELOPED A PINHOLE LEAK AND WAS REMOVED. NEXT A 3.5 X 20MM TAXUS LIBERTE STENT WAS PLACED IN OVERLAPPING FASHION WITH THE PREVIOUSLY PLACED STENT. POST-DILATION WAS PERFORMED USING A 4.0X 15MM QUANTUM BALLOON AT 20 ATM'S FOR 30 SECONDS. THIS BALLOON ALSO DEVELOPED A PIN HOLE LEAK. FINAL POST DILATATIONS WERE PERFORMED WITH A 4.0 X 20MM QUANTUM BALLOON AND FINAL RESULTS SHOWED 0-10% RESIDUAL STENOSIS WITH TIMI 3 FLOW. PER THE PHYSICIAN, THE PIN HOLE LEAKS WERE DUE TO THE PATIENT'S CALCIFIED ANATOMY. NO FRAGMENTS WERE LEFT IN THE BODY. THE FOLLOWING DAY, CARDIAC ENZYME ELEVATION CONSISTENT WITH A MYOCARDIAL INFARCTION (M.I.) OCCURRED. NO ACTION WAS TAKEN TO TREAT THE EVENT AND THE PATIENT WAS DISCHARGED LATER THAT SAME DAY ON ASPIRIN AND PRASUGREL. OF NOTE, THE PATIENT UNDER WENT A CONSULTATION FOR A FUTURE IMPLANT OF A DEFIBRILLATOR. PER THE PHYSICIAN, THE M.I. WAS LISTED AS "UNRELATED" TO THE STUDY STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808020400

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR 4.0X15 QUANTUM MAVERICK BALLOON| 4.0X20 QUANTUM MAVERICK BALLOON| 3.0X20 APEX BALLOON