BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 2803162 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06731
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    AVAIL MEDICAL PRODUCTS INCORPORATED
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE CATHETER HAD A DETACHED HUB AND SEPARATED IN THREE PIECES. THE SHAFT WAS STRETCHED AND 9CM OF THE SHAFT WAS TWISTED. THERE WAS BLOOD ON THE OUTER SURFACE OF THE CATHETER. THE SHAFT WAS TWISTED WITH BRAIDING EXPOSED 1MM FROM THE EDGE OF THE STRAIN RELIEF. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE 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

    DURING A PERCUTANEOUS CORONARY INTERVENTIONS (PCI) PROCEDURE, THE CATHETER HUB DETACHED AND SHAFT BREAKAGE OCCURRED. SINCE THE PATIENT HAD A VERY CALCIFIED AND VERY TORTUOUS PERIPHERAL ANATOMY, THE PHYSICIAN HAD A VERY DIFFICULT TIME GETTING INITIAL ACCESS AND ADVANCING A NON-BSC 6F GUIDE SHEATH. DIAGNOSTIC WAS PERFORMED SUCCESSFULLY AND A LESION WAS FOUND IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA). THE LESION ITSELF WAS NOT TORTUOUS OR CALCIFIED. THE PHYSICIAN HAD DIFFICULTY ADVANCING AND TORQUING THE FIRST 6F MACH1 GUIDE CATHETER. EVENTUALLY THE PROXIMAL HUB CRACKED BUT IT REMAINED ATTACHED. THE FIRST CATHETER WAS REMOVED AND A SECOND 6F MACH1 GUIDE CATHETER WAS INSERTED. THE SAME THING HAPPENED AND ITS HUB BROKE COMPLETELY OFF OUTSIDE THE PATIENT. THE SHAFT OF THE SECOND MACH1 GUIDE CATHETER WAS ALSO BROKEN INTO TWO PARTS. AFTER IT WAS REMOVED, A THIRD 6F MACH1 GUIDE CATHETER WAS INSERTED, WHICH ALSO HAD DIFFICULTY ADVANCING AND DEVELOPED A LEAK AT THE HUB WITH CONTRAST LEAKING OUT. AFTER IT WAS REMOVED, A FOURTH 6F MACH1 GUIDE CATHETER WAS INSERTED WHICH WAS ADVANCED ALL THE WAY INTO THE LESION. BUT IT POSSIBLY GOT KINKED AS THE PHYSICIAN COULD NOT GET CONTRAST TO FLOW THROUGH IT. AFTER IT WAS REMOVED, A FIFTH 7F MACH1 GUIDE CATHETER WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS FINE.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTIONS (PCI) PROCEDURE, THE CATHETER HUB DETACHED AND SHAFT BREAKAGE OCCURRED. SINCE THE PATIENT HAD A VERY CALCIFIED AND VERY TORTUOUS PERIPHERAL ANATOMY, THE PHYSICIAN HAD A VERY DIFFICULT TIME GETTING INITIAL ACCESS AND ADVANCING A NON-BSC 6F GUIDE SHEATH. DIAGNOSTIC WAS PERFORMED SUCCESSFULLY AND A LESION WAS FOUND IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA). THE LESION ITSELF WAS NOT TORTUOUS OR CALCIFIED. THE PHYSICIAN HAD DIFFICULTY ADVANCING AND TORQUING THE FIRST 6F MACH1 GUIDE CATHETER. EVENTUALLY, THE PROXIMAL HUB CRACKED, BUT IT REMAINED ATTACHED. THE FIRST CATHETER WAS REMOVED AND A SECOND 6F MACH1 GUIDE CATHETER WAS INSERTED. THE SAME THING HAPPENED AND ITS HUB BROKE COMPLETELY OFF OUTSIDE THE PATIENT. THE SHAFT OF THE SECOND MACH1 GUIDE CATHETER WAS ALSO BROKEN INTO TWO PARTS. AFTER IT WAS REMOVED, A THIRD 6F MACH1 GUIDE CATHETER WAS INSERTED, WHICH ALSO HAD DIFFICULTY ADVANCING AND DEVELOPED A LEAK AT THE HUB WITH CONTRAST LEAKING OUT. AFTER IT WAS REMOVED, A FOURTH 6F MACH1 GUIDE CATHETER WAS INSERTED, WHICH WAS ADVANCED ALL THE WAY INTO THE LESION. BUT IT POSSIBLY GOT KINKED AS THE PHYSICIAN COULD NOT GET CONTRAST TO FLOW THROUGH IT. AFTER IT WAS REMOVED, A FIFTH 7F MACH1 GUIDE CATHETER WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY AVAIL MEDICAL PRODUCTS INCORPORATED H74934356020 0050675111

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR TERUMO 6F GUIDE SHEATH| FIVE 6F MACH1 GUIDE CATHETER| 7F MACH1 GUIDE CATHETER