BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIPATH PERIPHERAL GUIDING CATHETER

    MDR report key: 1545638 · Received November 24, 2009

    Report

    Report Number
    2024168-2009-02213
    Event Type
    Injury
    Date Received
    November 24, 2009
    Date of Event
    October 30, 2009
    Report Date
    November 3, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQY
    PMA / PMN Number
    K994229
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #1 - RX HERCULINK 14 PLUS STENT SYSTEM (PART # UNK, LOT # UNK), IS BEING FILED UNDER MEDWATCH MFR # 3004742046-2009-00327. THE DEVICE IS NOT AVAILABLE FOR EVAL. THE LOT # IS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A F/U REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE #2 MALFUNCTION: GUIDING CATHETER & STENT ENTANGLEMENT/DAMAGED STENT. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: MEDICAL INTERVENTION/GI BLEED. IT WAS REPORTED THAT DURING A PROCEDURE, THE HERCULINK PLUS DEPLOYED SUCCESSFULLY IN THE RENAL ARTERY. WHEN AN ATTEMPT WAS MADE TO RETRIEVE THE VERIPATH GUIDING CATHETER, IT BECAME CAUGHT ON THE STENT. THE GUIDING CATHETER WAS PULLED USING FORCE CAUSING THE PROXIMAL PORTION OF THE STENT TO COMPLETELY STRETCH INTO THE AORTA. THE DISTAL PORTION OF THE STENT REMAINED FIRMLY IN THE TARGET LESION. AN UNSUCCESSFUL ATTEMPT WAS MADE TO SNARE THE STENT. THE STENT REMAINS IN THE ANATOMY. AS A CAUTIONARY MEASURE, THE PT WAS PLACED ON COUMADIN. LATER THAT EVENING, THE PT DEVELOPED A GASTROINTESTINAL BLEED. THE EXACT CAUSE OF THE BLEED IS UNK. CURRENT PT'S CONDITION IS IMPROVED. ANGIOGRAPHY IMAGES HAVE BEEN RECEIVED AND FINDINGS WILL BE INCLUDED ON THE SUPPLEMENTAL MEDWATCH REPORT. THOUGH REQUESTED, NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIPATH PERIPHERAL GUIDING CATHETER DQY ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SPARTACORE GUIDE WIRE| DEVICE #1: RX HERCULINK 14 PLUS STENT SYSTEM