BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA PTV CATHETER

    MDR report key: 4781434 · Received April 15, 2015

    Report

    Report Number
    2020394-2015-00235
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE WITH THE FACILITY TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE REPORT SOURCE DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS FAILURE MODE. THE DEVICE WAS RETURNED. THE INVESTIGATION IS CONFIRMED FOR A BREAK, AS A COMPLETE CIRCUMFERENTIAL OUTER SHAFT BREAK WAS FOUND AT THE PROXIMAL BALLOON JOINT. BASED ON THE VISUAL INSPECTION OF THE BREAK, IT APPEARED THAT EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE CATHETER SHAFT, AS THE EDGES OF THE BREAK WERE UNEVEN AND STRETCHED. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE OUTER SHAFT BREAK COULD NOT BE DETERMINED. POTENTIAL COMPLICATIONS RELATED TO A BREAK IS ADEQUATELY ADDRESSED IN THE CURRENT IFU (INSTRUCTIONS FOR USE). 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 PRIOR TO PATIENT USE, THE OUTER CATHETER SHAFT BROKE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252809 VIDA PTV CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93HX0100

    Patients

    Seq Age Sex Outcome Treatment
    1