BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2925630 · Received January 22, 2013

    Report

    Report Number
    2134265-2013-00564
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    October 21, 2012
    Report Date
    January 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN, WIRE LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED, WHICH IS CONSISTENT WITH HAVING POSITIVE PRESSURE APPLIED. A PINHOLE WAS NOTED ON THE BALLOON. TO VERIFY, POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE IN THE BALLOON WALL ADJACENT TO THE DISTAL MARKERBAND. THE BALLOON WAS WRINKLED/DAMAGED IN THE AREA PROXIMAL OF THE PINHOLE. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE WAS DAMAGE TO THE TIP. THERE WERE FOUR SHAFT KINKS 24CM, 24.5CM, 25.5CM, AND 26CM FROM THE TIP. THERE WAS NO OTHER DAMAGE TO THE DEVICE. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED SHAFT KINK. 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).

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE THE SHAFT WAS KINKED. THE 75 TO 90 % STENOSED TARGET LESION WAS LOCATED IN AN UNSPECIFIED LESION. A 2.00X12MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION; HOWEVER, RESISTANCE WAS ENCOUNTERED DUE TO THE CALCIFICATION AND TORTUOSITY OF THE VESSEL, RESULTING IN A SHAFT KINK. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30340 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912412200 15104137

    Patients

    Seq Age Sex Outcome Treatment
    1