BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 819895 · Received February 7, 2007

    Report

    Report Number
    6000093-2007-00280
    Event Type
    Malfunction
    Date Received
    February 7, 2007
    Date of Event
    January 9, 2007
    Report Date
    January 9, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: PRODUCT ANALYSIS VERIFIED THE DIFFICULTY AS STATED IN THE COMPLAINT. THE BALLOON CATHETER WAS RECEIVED AND A HYPOTUBE FRACTURE AND DISTAL POLYMER SHAFT ELONGATION WAS OBSERVED. THE CATHETER EXHIBITED BLOOD IN THE INFLATION LUMEN AND THE PROXIMAL SHAFT. THE MANIFOLD SECTION WAS NOT RETURNED FOR ANALYSIS. THE HYPOTUBE FRACTURE WAS LOCATED 67.2 CENTIMETERS PROXIMALLY FROM THE MID SHAFT BOND SITE. VISUAL AND MICROSCOPIC EXAMINATION OF THE FRACTURE FACE REVEALED EVIDENCE THAT THE HYPOTUBE HAD BEEN SEVERELY KINKED AT THE FRACTURE SITE. FURTHER EXAMINATION OF THE FRACTURE SITE DID NOT REVEAL ANY INHERENT MATERIAL DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS INCIDENT. THE CAUSE OF THE ORIGINAL KINK OR THE SUBSEQUENT FRACTURE COULD NOT BE DETERMINED. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE SHAFT ELONGATION DID NOT REVEAL ANY INHERENT MATERIAL DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE DAMAGE. AS THERE IS NO MENTION OF ANY REMOVAL DIFFICULTIES, THE EXACT CAUSE OF THE SHAFT ELONGATION COULD NOT BE DETERMINED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 9100248 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. THE ROOT CAUSE OF THE SHAFT DAMAGE AND HYPOTUBE FRACTURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PTCA PROCEDURE, THE SHAFT OF THE MAVERICK2 MONORAIL CATHETER BROKE WHILE ADVANCING THE DEVICE INTO THE GUIDE CATHETER. THE EVENT OCCURRED OUTSIDE THE PT AND THE DEVICE WAS NOT USED. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MONORAIL BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BOSTON SCIENTIFIC 12 X 4.0MM 9100248

    Patients

    Seq Age Sex Outcome Treatment
    1 *