BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAFLO BYPASS GRAFT

    MDR report key: 1073669 · Received July 9, 2008

    Report

    Report Number
    2020394-2008-00187
    Event Type
    Injury
    Date Received
    July 9, 2008
    Report Date
    June 17, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    PMA / PMN Number
    L983861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. THE SAMPLE REMAINS IMPLANTED, SO NO SAMPLE EVAL COULD BE PERFORMED. BASED ON THE INFO RECEIVED TO DATE, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNK. IT IS UNK IF PT OR PROCEDURAL ISSUES CONTRIBUTED TO THIS EVENT. THE CURRENT INFO FOR USE STATES: AGGRESSIVE AND/OR EXCESSIVE GRAFT MANIPULATION WHEN TUNNELING, OR PLACEMENT WITHIN A TOO TIGHT OR TOO SMALL TUNNEL, MAY LEAD TO SEPARATION OF THE SPIRAL BEADING AND/OR GRAFT BREAKAGE. THE DISTAL ANASTOMOSIS SHOULD BE MADE AFTER TUNNELING OR SUTURE DISRUPTION CAN OCCUR. DO NOT PASS THE CUFF PORTION (DISTAL END) OF THE DISTAFLO BYPASS GRAFT THROUGH A TUNNELER SHEATH OR THE TISSUE TUNNEL, AS THIS COULD LEAD TO SEPARATION OF THE SPIRAL BEADING AND/OR GRAFT BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (BELOW-KNEE) BK BYPASS WITH A SMALL CUFF BYPASS GRAFT DONE 10 MONTHS AGO, HAD THROMBOSIS THROUGHOUT THE BODY OF THE GRAFT. IT WAS ALLEGED THAT THIS WAS DUE TO A DETACHED RING FROM THE GRAFT BODY AROUND THE KNEE JOINT AREA. THE PLAN OF TREATMENT IS FOR DECLOTTING WITH A PTA BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAFLO BYPASS GRAFT DSY BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1