BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK²¿

    MDR report key: 2902143 · Received January 8, 2013

    Report

    Report Number
    2134265-2012-08303
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 76.4 CM DISTAL TO THE STRAIN RELIEF. A KINK WAS PRESENT IN THE PROXIMAL SECTION OF THE HYPOTUBE SHAFT AT 73CM DISTAL TO THE STRAIN RELIEF. IT IS NOTED THAT THE BREAK AND THE KINK, THAT WAS FOUND, IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE SHAFT. NO ISSUES WERE NOTED WITH THE BALLOON AND TIP PROFILES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. 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

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. IT WAS OBSERVED DURING THE PROCEDURE THAT THE SHAFT OF THE 2.0 X 20MM MAVERICK 2 MR BALLOON CATHETER FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. IT WAS OBSERVED DURING THE PROCEDURE THAT THE SHAFT OF THE 2.0 X 20MM MAVERICK 2 MR BALLOON CATHETER FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8582 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892820200 14997969

    Patients

    Seq Age Sex Outcome Treatment
    1