BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI-PLAST XT PTA BALLOON DILATATION CATHETER

    MDR report key: 1191430 · Received September 25, 2008

    Report

    Report Number
    2020394-2008-00274
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K941706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MFG LOT NUMBER. THE BALLOON CATHETER WAS RETURNED DETACHED FROM THE BALLOON. A 6 F INTRODUCER SHEATH (UNK BRAND) WAS RETURNED WITH THE BALLOON STUCK INSIDE WITH APPROX 8 MM OF THE BALLOON WAS STICKING OUT OF THE SHEATH. NO FLARING WAS NOTICED AT THE DISTAL TIP OF THE BALLOON. THE SHEATH HAD ACCORDIONED NEAR THE DISTAL END OF THE HUB. THIS MAY HAVE INDICATED THAT THERE WAS DIFFICULTY IN RETRACTING THE BALLOON THROUGH THE SHEATH. THE BALLOON COULD NOT BE REMOVED FROM THE SHEATH UNTIL IT WAS SOAKED IN WATER. THE CATHETER BREAK WAS EVALUATED UNDER MAGNIFICATION AND IT APPEARED THAT THERE WAS EVIDENCE OF EXCESSIVE STRETCHING, WHICH IS MOST LIKELY DUE TO DIFFICULTY IN REMOVING THE BALLOON FROM THE SHEATH. THE TWO DETACHED PIECES OF THE SAMPLE WERE PUT TOGETHER AND MEASURED. THE LENGTH WAS WITHIN SPECIFICATION, INDICATING THAT NO OTHER PIECES WERE MISSING. THIS CONFIRMS THE COMPLAINT FOR BALLOON DETACHMENT. THE ROOT CAUSE COULD NOT BE DETERMINED. THE CURRENT IFU (INFORMATION FOR USE) STATES: WARNING: 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. PRECAUTION: IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER, IT IS RECOMMENDED TO REMOVE THE BALLOON CATHETER AND GUIDEWIRE INTRODUCER SHEATH AS A SINGLE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY OF THE ILIAC ARTERY, THE PTA BALLOON ALLEGEDLY DETACHED FROM THE CATHETER AFTER ENTERING THE SHEATH TWICE. REPORTEDLY THE TRACKING ANATOMY WAS TORTUOUS AND CALCIFIED. THE BALLOON SUSTAINED TWO INFLATIONS OF 10ATMS HELD FOR 10 SECONDS EACH. AN INFLATION DEVICE WAS USED TO PRESSURIZE AND MEASURE ATMS. ALLEGEDLY, THE BALLOON DETACHED DURING WITHDRAWAL THROUGH A 6 F SHEATH. THE PHYSICIAN HAD COMPLETED THE PROCEDURE, HOWEVER, WAS UNABLE TO REMOVE THE DEVICE FROM THE SHEATH. THEY WERE REMOVED AS ONE UNIT. NO INTERVENTIONS WERE REQUIRED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-PLAST XT PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. GFRL0982

    Patients

    Seq Age Sex Outcome Treatment
    1