BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER RECANALIZATION CATHETER

    MDR report key: 4200908 · Received September 12, 2014

    Report

    Report Number
    2020394-2014-00417
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. THIS FILE WAS MISSING PATIENT DATA. SPOKE WITH INTERNATIONAL REPRESENTATIVE REGARDING PATIENT INFORMATION MISSING FROM THE FILE AND WAS ADVISED THAT (B)(6) HAS A PRIVACY LAWS THAT PROHIBITS THE TRANSFER OF PATIENT DATA. THEREFORE, THE PATIENT DETAILS ARE UNOBTAINABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER FOR THIS FAILURE MODE. THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. PER THE REPORTED EVENT DETAILS, THE PHYSICIAN BELIEVED THAT USER-RELATED ISSUES MAY HAVE CAUSED THE SUPPORT CATHETER TO KINK WITH THE RECANALIZATION CATHETER IN IT. HOWEVER, BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER 1 MINUTE 19 SECONDS OF ACTIVATION, THE RECANALIZATION CATHETER MADE AN UNUSUAL SOUND. DURING RETRACTION, THE CATHETER BECAME LODGED IN THE SUPPORT SHEATH. THE CATHETER AND SUPPORT SHEATH WERE REMOVED AS A SINGLE UNIT. UPON REMOVAL OF THE DEVICES, THE CATHETER MATERIAL WAS NOTED TO BE PULLED AWAY FROM THE METAL CATHETER TIP AND THE SUPPORT CATHETER WAS KINKED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566493 CROSSER RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFYA2927

    Patients

    Seq Age Sex Outcome Treatment
    1