BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3890151 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03456
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A .014¿ FORTE GUIDEWIRE WAS USED FOR FUNCTIONAL TESTING. THE GUIDEWIRE WAS ADVANCED INTO THE DISTAL TIP AND PROTRUDED THROUGH A TEAR IN THE INNER SHAFT AND BALLOON. MAGNIFIED INSPECTION OF THE DISTAL END OF THE CATHETER REVEALED A LONGITUDINAL TEAR IN THE INNER SHAFT AND BALLOON. THE TEAR BEGAN AT THE PROXIMAL END OF THE TIP AND EXTENDED TO THE DISTAL EDGE OF THE DISTAL MARKERBAND. THE TEAR MAY BE CONSISTENT WITH INTERACTION WITH THE CALCIFICATION WITHIN THE TARGET LESION OR A GUIDEWIRE, PRODUCT MANDREL, OR SHARP OBJECT RIPPING THROUGH THE DISTAL END OF THE DEVICE. INSPECTION OF THE MATERIAL IN THE AREA OF THE TEAR PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE OF THE DEVICE. THE TEAR CONTRIBUTED TO THE INABILITY TO INFLATE THE BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA UPPER ARM USING A NON BSC INTRODUCER SHEATH. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. AFTER A NON BSC GUIDEWIRE CROSSED THE LESION, A 4.0MMX30MMX143CM QUANTUM APEX¿ BALLOON CATHETER WAS USED TO PREDILATE THE LESION. DURING THE FIRST INFLATION IT WAS NOTICED THAT THE PRESSURE WOULD NOT RISE, THE BALLOON HAD RUPTURED AT 1 ATMOSPHERE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A 4.0X20 COYOTE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENTS STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA UPPER ARM USING A NON BSC INTRODUCER SHEATH. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT EXTERNAL ILIAC ARTERY. AFTER A NON BSC GUIDEWIRE CROSSED THE LESION, A 4.0MMX30MMX143CM QUANTUM APEX¿ BALLOON CATHETER WAS USED TO PREDILATE THE LESION. DURING THE FIRST INFLATION, IT WAS NOTICED THAT THE PRESSURE WOULD NOT RISE, THE BALLOON HAD RUPTURED AT 1 ATMOSPHERE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A 4.0X20 COYOTE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENTS STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367712 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H74939282403010 16876218

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: COMMAND (ABBOTT)| INTRODUCER SHEATH: 6F 90CM PARENT (MEDIKIT)