BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCARDIA MORPH ACCESSPRO STEERABLE INTRODUCER

    MDR report key: 3300373 · Received July 26, 2013

    Report

    Report Number
    3003610571-2013-00001
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BIOCARDIA, INC.
    Product Code
    DYB
    PMA / PMN Number
    K090999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INITIAL REPORT OF THIS EVENT, THE USER FACILITY DID NOT INDICATE TO BIOCARDIA THAT THEY CONSIDERED THIS TO BE A REPORTABLE EVENT. THE USER FACILITY DID NOT SENT A REPORT TO BIOCARDIA INDICATING THAT THEY HAD SUBSEQUENTLY DETERMINED THE EVENT TO BE REPORTABLE OR A COPY OF THEIR MEDWATCH REPORT. BIOCARDIA WAS MADE AWARE OF THE USER FACILITY REPORT BY RECEIPT OF A LETTER FROM FDA NOTIFYING US OF THE USER FACILITY REPORT. BIOCARDIA'S REVIEW OF THE COMPLAINT BASED ON THE INFO PROVIDED RESULTED IN A DETERMINATION THAT THE INCIDENT WAS NOT REPORTABLE BECAUSE NO INJURY WAS NOTED AND THERE WAS NO EVIDENCE THAT AN INJURY COULD RESULT IN THE EVENT OF A RECURRENCE. BIOCARDIA IS SUBMITTING THIS MDR TO REMAIN CONSISTENT WITH THE USER FACILITY DETERMINATION.

    Description of Event or Problem · 1

    HEAVILY SCARRED GROIN WHICH REQUIRED UNUSUAL FORCE TO PLACE AND RETRIEVE DEVICE. DEVICE WORKED NORMALLY THROUGHOUT CASE. UPON RETRIEVAL A WIRE WAS NOTED TO BE STICKING OUT OF SLIT ON THE DISTAL END. FLUOROSCOPIC ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH PT. PT IS FINE AND THERE WAS NO ADVERSE OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351890 BIOCARDIA MORPH ACCESSPRO STEERABLE INTRODUCER CATHETER INTRODUCER DYB BIOCARDIA, INC. MAP645 01147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK