BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM¿ MAVERICK¿

    MDR report key: 3113591 · Received May 15, 2013

    Report

    Report Number
    2134265-2013-03479
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A QUANTUM MAVERICK BALLOON CATHETER WITH A STOPCOCK ATTACHED TO THE MANIFOLD. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS A PINHOLE IN THE BALLOON WALL MATERIAL 6MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THE BALLOON WALL MATERIAL HAD SCRATCHES. THE OUTER SHAFT WAS KINKED 1.75CM FROM THE DISTAL TIP. THE KINK AND SCRATCHES WERE ALIGNED WITH THE PINHOLE. INSPECTION OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, DIFFICULTY CROSSING THE LESION OCCURRED. THE 80% RESTENOSED TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 15MM X 3.5MM QUANTUM MAVERICK BALLOON CATHETER COULD NOT CROSS THE LESION. THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT' STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A PINHOLE ON THE BALLOON WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215563 QUANTUM¿ MAVERICK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015350 15329045

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR