BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUTTING BALLOON

    MDR report key: 3257408 · Received July 31, 2013

    Report

    Report Number
    2134265-2013-05086
    Event Type
    Injury
    Date Received
    July 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K040155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE CANNOT BE REVIEWED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A BALLOON RUPTURE AND DETACHMENT OCCURRED. INDICATION FOR PROCEDURE: CAD, SUBACUTE INFEROLATERAL MI. PROCEDURE: CABG X2. DOCUMENTATION REFLECT. "THE HEART WAS LIFTED AND THE SECOND OBTUSE MARGINAL WAS EXAMINED. IT WAS FULL OF THROMBUS AND FELT HARD AS IF THERE WAS A STENT IN IT. UPON INCISION OF ARTERY, A ONE INCH SEGMENT OF CATHETER WITH A RUPTURED ANGIOPLASTY BALLOON AT THE END WAS RETRIEVED. GROSS PATHOLOGY REFLECTED A CATHETER/TIP BALLOONS 0.5 TO 2.0 EM WITH A RANGE IN DIAMETER FROM 0.2 TO 0.3 EM. THE RETAINED SURGICAL ITEM (RBI) WAS GROSSLY EXAMINED BY THE ABBOTT REP. IT IS UNCLEAR AT THIS TIME THE EXACT BALLOON DEVICE THAT RUPTURED AS MULTIPLE DIFFERENT MANUFACTURER'S BALLOON WERE USED WITHIN THE OBTUSE MARGINAL SEGMENT (OMS) VESSEL DURING THE CARDIAC CATHETERIZATION (CC) IN QUESTION TWO WEEKS AGO. CC FILM REVIEWED BY PHYSICIAN POST PROCEDURE. QUESTION OF IDENTIFICATION OF RSI ON FILM. PATIENT IS DOING WELL WITH NO SUBSEQUENT COMPLICATIONS. SUSPECTED PERCUTANEOUS TRANS LUMINAL CORONARY ARTERY (PTCA) WITH BARE-METAL STENT OF THE LEFT CIRCUMFLEX, POSTERIOR LEFT VENTRICLE (PLV) AND PTCA OF THE OMS FOLLOWED BY PTCA OF OM2 AND RIGHT CORONARY ARTERY (RCA). DURING CC PROCEDURE IN QUESTION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE. INTERVIEW WITH PHYSICIAN REFLECTS MULTIPLE BALLOON RUPTURES THROUGHOUT THE PROCEDURE SECONDARY TO HEAVY PLAQUE. NO INDICATION DURING PROCEDURE THAT BALLOON WAS RETAINED AS BALLOON INSPECTED UPON REMOVAL. REPORTED EVENT TO ABBOTT REP, WHICH IS CONDUCTING THEIR OWN INTERNAL INVESTIGATION. A BSC 2.5X10 CUTTING BALLOON WAS USED IN THE CIRCUMFLEX AND A BSC 2.0X6 CUTTING BALLOON WAS USED IN THE POSTERIOR LEFT VENTRICLE. CONFIRMATION WAS OBTAINED DURING FOLLOW UP WITH THE USER FACILITY THAT THERE WERE NO BLADES ON THE BALLOON OF THE COMPLAINT DEVICE AND THAT THE ABBOTT REP WAS ALMOST CERTAIN THAT IT WAS AN ABBOTT BALLOON, BUT COULDN¿T COMMIT 100% BECAUSE THERE WAS A LOT OF THROMBUS AROUND IT. NO BSC DEVICE COULD BE IDENTIFIED FROM THE ONLY LOT NUMBERS AVAILABLE (277968 AND 277966) FROM THE USER FACILITY. THE DEVICE IS BEING RETAINED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357417 CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK103

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention