BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILTRAC .035 PERIPHERAL DILATATION CATHETER

    MDR report key: 1800042 · Received August 12, 2010

    Report

    Report Number
    3004742046-2010-00356
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 19, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AGILTRAC .035 PERIPHERAL DILATATION CATHETER, (B)(4), LOT # 9063051 INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH BLOOD AND CONTRAST IN THE BALLOON. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON. FLUID LEAKED OUT OF A PINHOLE 3MM PROXIMAL TO THE DISTAL MARKER. THERE WERE MULTIPLE SCRATCHES THROUGHOUT THE ENTIRE LENGTH OF THE BALLOON. BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MANUFACTURING OR FROM USE OF THE PRODUCT. DURING USE THERE CAN BE AN INTERACTION WITH ANATOMY AND/OR ACCESSORY DEVICES, WHICH CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. THERE WAS NO REPORT OF ANY LEAK IN THE PRODUCT NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE LEAK TESTED ON-LINE AND A SAMPLING OF UNITS FROM ALL CATHETER LOTS ARE RUPTURE TESTED PRIOR TO RELEASE FOR USE IN THE FINISHED GOOD LOT. IN THIS CASE, THE SCRATCHES NOTED THROUGHOUT THE ENTIRE LENGTH OF THE BALLOON SUGGEST THAT THE BALLOON INTERACTED WITH THE ANATOMY AND/OR ACCESSORY DEVICES. ADDITIONALLY, THE RUPTURE AND BALLOON DAMAGE WAS ALSO NOTED ON THE FIRST RETURNED AGILTRAC USED IN THIS PROCEDURE, FURTHER SUGGESTING THAT THE RUPTURES ARE LIKELY RELATED TO INTERACTION WITH THE ANATOMY AND/OR ACCESSORY DEVICES. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ADDITIONALLY, LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. IN THIS CASE, THE BALLOON RUPTURE APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION OF A PRODUCT RELATED DEFICIENCY.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING DILATATION IN AN UNSPECIFIED VESSEL, THE AGILTRAC DILATATION CATHETER BALLOON RUPTURED BELOW 14 ATMOSPHERES. A SECOND AGILTRAC DILATATION CATHETER BALLOON ALSO RUPTURED BELOW 14 ATMOSPHERES. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILTRAC .035 PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 9100851

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR (B)(4), LOT # 9063051| AGILITRAC .035 PERIPHERAL DILATATION CATHETER