BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1002002 · Received February 22, 2008

    Report

    Report Number
    2024168-2008-00141
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 25, 2008
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD VISIBLE ON THE INFLATION LUMEN, BALLOON, AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED. THE HYPOTUBE WAS SEPARATED 21.7 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THE PROXIMAL PORTION OF THE SEPARATION WAS NOT RETURNED. THE FRACTURE FACE WAS OVALED AS IF KINKED PRIOR TO SEPARATION. THERE WERE FIVE KINKS IN THE SHAFT 1.7 CM, 2.4 CM, 3.1 CM, 11.3 CM, AND 13 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE TWO KINKS IN THE INFLATION LUMEN 10.5 CM AND 20.8 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS A TEAR IN THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 7 MM. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THEIR ANALYSIS AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - REQUIRED INTERVENTION. REPORTING RATIONALE: SHAFT SEPARATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: SHAFT SEPARATION. IT WAS REPORTED THAT THE DEVICE WAS BEING USED TO TREAT THE POPLITEAL ARTERY IN A PATIENT, WHICH WAS SCHEDULED FOR SURGERY TO TREAT THE DISEASE IN THAT ARTERY. THE BALLOON BECAME STUCK IN THE SHEATH BEFORE INFLATION. IT WAS ATTEMPTED TO BE REMOVED BY APPLYING EXCESSIVE FORCE. THE DEVICE SUBSEQUENTLY SEPARATED AND WAS ATTEMPTED TO BE SNARED, UNSUCCESSFULLY. THE PATIENT THEN PROCEEDED TO THE SCHEDULED SURGERY (FEMPOP) TO TREAT THE FEMORAL DISEASE, DURING WHICH THE SEPARATED PORTION OF THE DEVICE WAS RETRIEVED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER 74LOX LOX ABBOTT VASCULAR - CARDIAC THERAPIES NA 7061333

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention