BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA PTV CATHETER

    MDR report key: 5628520 · Received May 3, 2016

    Report

    Report Number
    2020394-2016-00416
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    April 7, 2016
    Report Date
    April 7, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA. VISUAL INSPECTION: THE SAMPLE WAS RETURNED. THE BALLOON SIZE WAS PRINTED ON THE BALLOON HUB OF THE CATHETER AND IDENTIFIED THE RETURNED SAMPLE AS A 16MM X 6CM BALLOON. THE BALLOON APPEARED TO HAVE BEEN PREVIOUSLY INFLATED. NO OTHER ANOMALIES WERE OBSERVED. X-RAY: THE BALLOON WAS EXAMINED VIA X-RAY IMAGING PRIOR TO FUNCTIONAL TESTING, AND THE MARKER BANDS WERE NOT VISIBLE. FUNCTIONAL/PERFORMANCE EVALUATION: THE BALLOON WAS CUT USING A RAZOR IN ORDER TO DETERMINE WHETHER THE MARKER BANDS WERE PRESENT. UPON OPENING THE BALLOON, BOTH MARKER BANDS WERE MISSING FROM THE INNER CATHETER. THE GLUE BULLET WAS INTACT AND IN THE CORRECT LOCATION, INDICATING THAT THE MARKER BANDS DID NOT MOVE FURTHER PROXIMAL ON THE INNER CATHETER SHAFT. NO DAMAGE WAS NOTED TO THE CATHETER AND THE MARKER BANDS WERE NOT PRESENT. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. CONCLUSION: THE INVESTIGATION IS CONFIRMED FOR COMPONENT MISSING, AS BOTH MARKER BANDS WERE MISSING ON THE RETURNED DEVICE. THE MISSING MARKER BANDS IS A SUPPLIER RELATED ISSUE. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: WHEN THE CATHETER IS EXPOSED TO THE VASCULAR SYSTEM, IT SHOULD BE MANIPULATED WHILE UNDER HIGH-QUALITY FLUOROSCOPIC OBSERVATION. DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION. PRECAUTIONS: CAREFULLY INSPECT THE CATHETER PRIOR TO USE TO VERIFY THAT CATHETER HAS NOT BEEN DAMAGED DURING SHIPMENT AND THAT ITS SIZE, SHAPE AND CONDITION ARE SUITABLE FOR THE PROCEDURE FOR WHICH IT IS TO BE USED. DO NOT USE IF PRODUCT DAMAGE IS EVIDENT. DILATATION PROCEDURES SHOULD BE CONDUCTED UNDER HIGH-QUALITY FLUOROSCOPIC GUIDANCE. USE OF THE VIDA PTV DILATATION CATHETER: POSITION THE BALLOON RELATIVE TO THE VALVE TO BE DILATED, ENSURE THE GUIDEWIRE IS IN PLACE AND, WHILE ENSURING THE BALLOON IS HELD IN A STATIC POSITION, INFLATE THE BALLOON TO THE APPROPRIATE PRESSURE. APPLY NEGATIVE PRESSURE TO FULLY EVACUATE FLUID FROM THE BALLOON. CONFIRM THAT THE BALLOON IS FULLY DEFLATED UNDER FLUOROSCOPY. WHILE MAINTAINING NEGATIVE PRESSURE AND THE POSITION OF THE GUIDEWIRE, WITHDRAW THE DEFLATED CATHETER OVER THE WIRE THROUGH THE INTRODUCER SHEATH. USE OF A GENTLE COUNTER CLOCKWISE MOTION MAY BE USED TO HELP FACILITATE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT IN THE MID SFA, THE HEALTH CARE PROVIDER ALLEGED THAT ONLY ONE MARKER BAND WAS VISIBLE UNDER FLUOROSCOPY. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED UNDER LOW PRESSURE TO LOCATE THE POSITION OF THE BALLOON AND THEN TREATED THE LESION WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282891 VIDA PTV CATHETER PTA DILATATION BALLOON CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93LZ0217

    Patients

    Seq Age Sex Outcome Treatment
    1