BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMA ANGIOGRAPHIC CATHETERS

    MDR report key: 2023254 · Received February 15, 2011

    Report

    Report Number
    1628221-2011-00014
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DQO
    PMA / PMN Number
    K943739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS EXAMINED VISUALLY AND THE COMPLAINT WAS CONFIRMED. THE CATHETER TIP WAS PARTIALLY SEPARATED FROM THE BODY TUBING AT THE FUSE ZONE. VISUAL INSPECTION UNDER MAGNIFICATION DID NOT REVEAL ANY ANOMALIES AT THE FUSE ZONE. SAMPLES MET OR EXCEEDED TENSILE TESTING SPECIFICATIONS. SAMPLES FROM THE PROCESS MACHINES WERE SLICED OPEN AND THE FUSE ZONE INSPECTED, NO ANOMALIES IDENTIFIED. UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. NO CONCLUSION CAN BE DRAWN. METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED. RESULTS: UNABLE TO DETERMINE ROOT CAUSE OF REPORTED FAILURE. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    DURING A SELECTION OF THE LEFT CORONARY ARTERY THE TIP OF THE CATHETER PARTIALLY SEPARATED FROM THE CATHETER BODY WHILE IN THE PT. THE PHYSICIAN WAS ABLE TO INSERT A WIRE THROUGH THE PARTIALLY SEPARATED TIP AND PULL THE CATHETER AND WIRE OUT OF THE PT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMA ANGIOGRAPHIC CATHETERS CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO MERIT MEDICAL SYSTEMS, INC. E189583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SALINE CONTRAST MEDIA| WHISPER WIRE