BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7 FR VIDA PTV CATHETER

    MDR report key: 5275178 · Received December 8, 2015

    Report

    Report Number
    2020394-2015-01978
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 12, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW WAS CONDUCTED. THE LOT MET ALL RELEASE CRITERIA.VISUAL/MICROSCOPIC INSPECTION: THE DEVICE WAS RETURNED USED. THE BALLOON SIZE FOR THIS PRODUCT IS PRINTED ON THE BALLOON HUB OF THE CATHETER AND IDENTIFIED THE RETURNED SAMPLE AS A 14MM X 4CM X 100CM BALLOON. LOOSE FIBERS WERE NOTED AT THE DISTAL CONE. FIBER STRANDS WERE NOTED TO BE UNRAVELED AT THIS LOCATION, MEASURING 45.2CM IN LENGTH. THE OUTER PEBAX LAYER WAS ALSO PEELING OFF THE BALLOON AT THIS LOCATION. THE BALLOON WAS RETURNED PARTIALLY INFLATED. NO OTHER ANOMALIES WERE OBSERVED ALONG THE LENGTH OF THE DEVICE. FUNCTIONAL/PERFORMANCE EVALUATION: THE PATENCY OF THE GUIDEWIRE LUMEN WAS TESTED USING AN IN-HOUSE 0.035¿ GUIDEWIRE, AND IT PASSED WITHOUT ISSUE. THE INFLATION HUB WAS CONNECTED TO AN INFLATION DEVICE AND THE PARTIALLY INFLATED BALLOON WAS ABLE TO BE DEFLATED WITHOUT ISSUE. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. UPON INFLATION, THE BALLOON INFLATED ASYMMETRICALLY AND RUPTURED AT 3ATM. THE BALLOON RUPTURING IS AN INCIDENTAL FINDING, AS IT WAS NOT REPORTED BY THE USER AND LIKELY RUPTURED DUE TO THE UNRAVELED FIBERS AND PEELED PEBAX. THE RUPTURE WAS LOCATED 1.2CM FROM THE DISTAL TIP AND EXTENDED LONGITUDALLY FOR 2.3CM. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO SAMPLE CONDITION (I.E. UNRAVELED FIBERS AND BALLOON RUPTURE)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 UNRAVELED FIBERS AND PEELED PEBAX. THE INVESTIGATION IS INCONCLUSIVE FOR SHEATH RELATED RETRACTION ISSUES, AS FUNCTIONAL TESTING FOR SHEATH RETRACTION ISSUES COULD NOT BE PERFORMED DUE TO THE POOR SAMPLE CONDITION (I.E. UNRAVELED FIBERS). THE BALLOON WAS INFLATED NEAR A STENT AND THERE MAY HAVE BEEN AN INTERACTION BETWEEN THE STENT AND BALLOON WHICH CONTRIBUTED TO THE UNRAVELED FIBERS AND PEELED PEBAX. THE BALLOON WAS ALSO RETURNED PARTIALLY INFLATED. THEREFORE, IT IS POSSIBLE THAT THE USER DID NOT FULLY DEFLATE THE BALLOON, RESULTING IN THE RETRACTION DIFFICULTY THROUGH THE INTRODUCER SHEATH. THE PARTIALLY INFLATED BALLOON WAS ABLE TO BE DEFLATED WITHOUT ISSUE DURING FUNCTIONAL TESTING. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT.LABELING REVIEW: THE CURRENT VIDA PTV CATHETER INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON VALVULOPLASTY CATHETER WAS ALLEGEDLY DIFFICULT TO RETRACT THROUGH THE SHEATH AFTER USE IN THE SVC. IT WAS FURTHER REPORTED THAT UPON REMOVAL FROM THE SHEATH THE FIBERS OF THE BALLOON WERE ALLEGEDLY UNRAVELED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803856 7 FR VIDA PTV CATHETER BALLOON VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93HZ0123

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR