BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PTA BALLOON DILATATION CATHETER

    MDR report key: 4092401 · Received September 5, 2014

    Report

    Report Number
    2020394-2014-00402
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 HEALTH PROFESSIONAL AT THE USER FACILITY DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION CONFIRMED A COMPLETE CIRCUMFERENTIAL OUTER CATHETER BREAK AT THE PROXIMAL BALLOON GLUE JOINT. THE BREAK WAS EXAMINED UNDER (B)(4) MAGNIFICATION AND THE EDGES AT BOTH ENDS OF THE BREAK WERE STRETCHED AND JAGGED, INDICATING EXCESSIVE FORCE CAUSED THE BREAK. THE DISTAL TIP OF THE BALLOON WAS PROTRUDING FROM THE DISTAL END OF THE INTRODUCER SHEATH AND THE BALLOON MATERIAL WAS PARTIALLY PROLAPSED OVER THE DISTAL TIP OF THE CATHETER. THE INVESTIGATION CONFIRMED RETRACTION ISSUES, AS THE DISTAL TIP OF THE INTRODUCER SHEATH WAS FLARED AND THE BALLOON CATHETER COULD NOT BE RETRACTED THROUGH THE SHEATH. THE BALLOON WAS ADVANCED THROUGH THE INTRODUCER SHEATH AND NO SIGN OF A BALLOON RUPTURE WAS NOTED. THE PATENCY OF THE GUIDEWIRE LUMEN DEFLATION ISSUES AS FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE BREAK AT THE GLUE JOINT. IT IS LIKELY THAT THE BREAK IN THE OUTER CATHETER WAS A RESULT OF THE RETRACTION ISSUES. THE RETRACTION ISSUES WERE LIKELY CAUSED BY THE BALLOON NOT BEING FULLY DEFLATED. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE INFLATION AND DEFLATION ISSUES COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WOULD NOT DEFLATE IN THE SUBCLAVIAN VEIN. THE BALLOON CATHETER WAS DIFFICULT TO REMOVE THROUGH THE SHEATH; THEREFORE, THE CATHETER AND SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545826 ATLAS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1