BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2990905 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01334
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX MONORAIL (MR) BALLOON CATHETER WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS A COMPLETE SEPARATION OF THE HYPOTUBE. THE HYPOTUBE SEPARATION WAS 71.5 CM FROM THE HUB. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. THERE WAS CONTRAST IN THE INFLATION LUMEN, WIRE LUMEN AND ON THE OUTSIDE OF THE CATHETER AND BALLOON. THE BALLOON WAS TIGHTLY FOLDED. THE HYPOTUBE WAS KINKED 3.5 CM FROM THE FRACTURED DISTAL END. THERE IS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT. PRODUCT ANALYSIS CONFIRMED THE REPORTED KINK AND CONFIRMED A BROKEN HYPOTUBE. 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)(4) 2013. IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY TREATMENT PROCEDURE, THE 3.0 X 20 MM NC QUANTUM APEX BALLOON WAS FOUND TO BE KINKED IN 2 PLACES. HOWEVER, THE PRODUCT ANALYSIS REVEALED A SHAFT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95898 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912420300 15654435

    Patients

    Seq Age Sex Outcome Treatment
    1