BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MR BALLOON CATHETER

    MDR report key: 1220275 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04184
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS CONFIRMED THE SHAFT BREAK STATED IN THE COMPLAINT. THERE WAS ALSO TIP DAMAGE NOTED. THE CATHETER WAS RETURNED IN TWO PIECES WITHOUT THE CARRIER TUBE. THE BREAK OCCURRED 71.5 CM FROM THE DISTAL EDGE OF THE HUB. THERE WAS NO SIGN OF ELONGATION OR STRETCHING FOUND AT THE BREAK. TIP DAMAGE WAS ALSO OBSERVED ON THE RETURNED DEVICE. THE MANUFACTURING RECORDS FOR THE REPORTED BATCH HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THOUGH THE EXACT CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED, THE MOST PROBABLE ROOT CAUSE IS CONSIDERED OPERATIONAL CONTEXT. THIS IS DUE TO THE LIKELIHOOD THAT THE REPORTED DAMAGE IS ATTRIBUTABLE TO PROCEDURAL FACTORS AND/OR INTERACTION WITH PT ANATOMY OR OTHER DEVICES, AND DUE TO LACK OF EVIDENCE INDICATING A DEVICE RELATED ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE, A SHAFT FRACTURE OCCURRED. THE QUANTUM MAVERICK BALLOON'S MONORAIL SECTION BROKE MID SHAFT, WHILE THE BALLOON WAS BEING ADVANCED TO THE TARGET VESSEL. THE PHYSICIAN MENTIONED THAT LITTLE PRESSURE WAS APPLIED WHILE ADVANCING. THE DEVICE WAS REMOVED WITHOUT INCIDENT. THERE WERE NO COMPLICATIONS AND THE PT WAS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MR BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15X4.0 MM 11791893

    Patients

    Seq Age Sex Outcome Treatment
    1