BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3970356 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04439
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN EMERGE BALLOON CATHETER WITH NO OTHER DEVICES. THE HYPOTUBE SHAFT WAS BROKEN 68CM FROM THE HUB. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THERE WERE NUMEROUS HYPOTUBE KINKS. THE INNER DIAMETER (ID) OF THE WIRE LUMEN WAS MEASURED AT BOTH ENDS WITH A CALIBRATED PIN GAUGE SET. FUNCTIONAL TESTING WAS COMPLETED BY SUCCESSFULLY ADVANCING THE A FORTE GUIDEWIRE THROUGH THE TIP AND WAS ADVANCED THOUGH THE CATHETER WITH NO UNUSUAL RESISTANCE. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 2.00MM X 12MM EMERGE¿ BALLOON CATHETER WAS SELECTED AND ADVANCED ON AN UNKNOWN MANUFACTURER¿S GUIDE WIRE. DURING ADVANCEMENT THE BALLOON SHAFT AND THE HEMOSTASIS VALVE KINKED. RESISTANCE WAS ENCOUNTERED AS THE PHYSICIAN WAS ADVANCING THE GUIDEWIRE INTO THE BALLOON CATHETER. IT WAS THEN NOTED THAT THE DISTAL TIP OF THE BALLOON SEPARATED AND REMAINED ON THE GUIDEWIRE. THE BALLOON CATHETER AND GUIDEIRE WERE REMOVED AS ONE UNIT. THIS DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 2.00MM X 12MM EMERGE¿ BALLOON CATHETER WAS SELECTED AND ADVANCED ON AN UNKNOWN MANUFACTURER¿S GUIDE WIRE. DURING ADVANCEMENT THE BALLOON SHAFT AND THE HEMOSTASIS VALVE KINKED. RESISTANCE WAS ENCOUNTERED AS THE PHYSICIAN WAS ADVANCING THE GUIDEWIRE INTO THE BALLOON CATHETER. IT WAS THEN NOTED THAT THE DISTAL TIP OF THE BALLOON SEPARATED AND REMAINED ON THE GUIDEWIRE. THE BALLOON CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. THIS DEVICE NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448013 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918912200 17024464

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR