BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX¿

    MDR report key: 2872859 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07553
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION SHOWED THE BALLOON WAS BUNCHED-UP. THE INNER AND OUTER SHAFTS WERE BUCKLED IN MULTIPLE LOCATIONS BETWEEN THE GUIDEWIRE EXIT NOTCH AND THE PROXIMAL BALLOON BOND. THE GUIDEWIRE WAS PROTRUDING 41CM FROM THE TIP. GENTLY PULLING ON THE WIRE CONFIRMED THAT THE WIRE WAS STUCK IN THE LUMEN OF THE CATHETER. THE OUTER DIAMETER OF THE WIRE WAS .0135" WHICH IS CONSISTENT WITH A .014" GUIDEWIRE. THE BUCKLING OF THE INNER AND OUTER SHAFT PREVENTED REMOVAL OF THE GUIDEWIRE FROM THE CATHETER. THE CATHETER WAS LOCKED-UP ON THE GUIDEWIRE. THERE IS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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

    SAME CASE AS MFR#: 2134265-2012-07891. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE THE BALLOON STUCK ON THE WIRE. THE DETAILS OF THE LESION ARE UNKNOWN. THE APEX OTW 12MM X 2.50MM BECAME STUCK ON THE MAILMAN 300CM GUIDEWIRE AND THEY HAD TO PULL THE ENTIRE SYSTEM OUT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2012-07891. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE THE BALLOON STUCK ON THE WIRE. THE DETAILS OF THE LESION ARE UNKNOWN. THE APEX OTW 12MM X 2.50MM BECAME STUCK ON THE MAILMAN 300CM GUIDEWIRE AND THEY HAD TO PULL THE ENTIRE SYSTEM OUT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895812250 15515540

    Patients

    Seq Age Sex Outcome Treatment
    1