BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 3241400 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-05174
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SHAFT WAS TWISTED 3MM FROM THE STRAIN RELIEF. THERE WAS ALSO A HOLE IN THE SHAFT WALL WITH BRAIDING EXPOSED AT THE SAME LOCATION AS THE TWIST. THE CONFIRMED SHAFT HOLE/PERFORATION NEAR THE HUB IS CONSISTENT WITH THE REPORTED BROKEN SHAFT. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE OR BROKEN SHAFT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY DIAGNOSTIC PROCEDURE, CATHETER FRACTURE OCCURRED. THE PHYSICIAN ADVANCED THE 6F MACH1 KIMNY MINI GUIDE CATHETER. HOWEVER, AS THE PHYSICIAN ATTEMPTED TO TURN THE CATHETER INTO THE CORONARY VESSEL, THE PHYSICIAN NOTED BLOOD FLOW THROUGH THE CATHETER AT A FRACTURE SITE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY DIAGNOSTIC PROCEDURE, CATHETER FRACTURE OCCURRED. THE PHYSICIAN ADVANCED THE 6F MACH1 KIMNY MINI GUIDE CATHETER. HOWEVER, AS THE PHYSICIAN ATTEMPTED TO TURN THE CATHETER INTO THE CORONARY VESSEL, THE PHYSICIAN NOTED BLOOD FLOW THROUGH THE CATHETER AT A FRACTURE SITE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340669 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749343565840 0050703160

    Patients

    Seq Age Sex Outcome Treatment
    1