BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE 6F

    MDR report key: 1643145 · Received March 25, 2010

    Report

    Report Number
    3003610571-2010-00001
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 11, 2010
    Manufacturer
    BIOCARDIA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K042553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE REPORT DOCUMENTATION AND CINES OF THE PROCEDURE WERE PROVIDED BY THE USER FACILITY. REVIEW OF THESE MATERIALS CLEARLY SHOWED THAT THE DEFLECTABLE TIP WAS DAMAGED DURING THE CASE, AS EVIDENCED BY IMAGES OF THE DISTAL TIP OF THE CATHETER THAT WAS BENT BACKWARDS. THE INSTRUCTIONS FOR USE FOR THIS DEVICE CAUTIONS AGAINST THE PRACTICE AND STATES THAT DAMAGE MAY OCCUR. ANALYSIS OF THE RETURNED PORTION OF THE DEVICE SHOWED THAT THE DISTAL PORTION OF THE DEVICE HAD SEPARATED FROM THE SHAFT OF THE CATHETER, 30 MM FROM THE DISTAL END. THE EXAMINATION SHOWED EVIDENCE OF FAILURE CONSISTENT WITH THE DEFLECTABLE TIP BEING BENT BACKWARDS AT THE SEPARATION POINT. THE SEPARATED DISTAL PORTION OF THE DEVICE WAS DISCARDED BY THE USER FACILITY AND NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFO AND ATTEMPTS TO RECREATE THE FAILURE, THE FOLLOWING SEQUENCE OF EVENTS ARE BELIEVED TO HAVE CAUSED THIS EVENT: AS THE PHYSICIAN WAS ATTEMPTING TO DRIVE A STIFF GUIDEWIRE PAST THE CONTRALATERAL OCCLUSION THROUGH A DEFLECTED DISTAL END, THE DEVICE WAS ADVANCED AGAINST THE OCCLUSION AND/OR ROTATED, CAUSING THE DEFLECTION ZONE TO BE BENT BACKWARDS. THIS LIKELY CAUSED A KINK IN THE DISTAL TIP OF THE CATHETER. ADDITIONAL TORSIONAL MANIPULATION CAUSED THE CRACK TO PROPAGATE AND ULTIMATELY CAUSE THE DEFLECTABLE ELEMENT OF THE TIP TO FRACTURE. UPON REMOVAL OF THE CATHETER FROM THE PT, THE DEVICE WAS RETRACTED AGAINST THE DISTAL TIP OF THE INTRODUCER SHEATH, WHICH IT COULD NOT ENTER, CAUSING THE REMAINDER OF THE CATHETER TIP MATERIALS TO BE STRETCHED TO FAILURE CAUSING THE DEFLECTABLE DISTAL TIP TO SEPARATE FROM THE CATHETER. CONCLUSION - THE DEVICE WAS USED IN A MANNER THAT WAS INCONSISTENT WITH THE IFU.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A TREATMENT OF THE LEFT ILIAC ARTERY, THE USER REPORTED THAT THE DISTAL PORTION OF THE CATHETER HAD SEPARATED FROM CATHETER. THE 6F MORPH GUIDE CATHETER WAS DEFLECTED IN THE ILIAC ARTERY, THE PHYSICIAN ADVANCED A STIFF GUIDEWIRE AND OBSERVED THAT THE GUIDEWIRE EXITED THROUGH THE WALL OF THE DEFLECTION ZONE OF THE DEVICE. WHEN THE PHYSICIAN REMOVED THE CATHETER, THE DISTAL END SEPARATED AND REMAINED INSIDE THE PT ADJACENT TO THE DISTAL END OF THE INTRODUCER SHEATH IN THE COMMON FEMORAL ARTERY. THE PIECE THAT WAS SEVERED WAS RETRIEVED BY A VASCULAR SURGEON. THIS WAS ACCOMPLISHED WITHOUT COMPLICATION AND THE REMAINDER OF THE THERAPEUTIC PROCEDURE WAS COMPLETED AND NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE 6F GUIDE CATHETER DQY BIOCARDIA, INC. 01066 00715

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention