BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 1984350 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00811
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - INFLATION ABOVE RATED BURST PRESSURE (RPB). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT NOTED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD IN THE HUB, INFLATION LUMEN, BALLOON AND GUIDE WIRE LUMEN. THERE WAS NO CONTRAST VISIBLE. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE BALLOON CATHETER WAS INSERTED INTO THE PATIENT AND THE BALLOON RUPTURED INSIDE OF THE PATIENT. BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MANUFACTURING DEFICIENCY (SUCH AS DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL) OR FROM USE OF THE DEVICE. 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. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF MANUFACTURING, ALL BALLOONS ARE INFLATED ONLINE TO 2 BARS ABOVE RATED BURST PRESSURE AND A SAMPLING OF UNITS ARE RUPTURE TESTED PRIOR TO RELEASE FOR USE. ANALYSIS OF THE RETURNED DEVICE NOTED THE BALLOON WAS RETURNED LOOSELY FOLDED. THE BALLOON HAD A RADIAL RUPTURE AND WAS SEPARATED 3CM DISTAL TO THE PROXIMAL BALLOON TAPER WITH THE FRACTURE FACE JAGGED. THE SHAFT INCLUDING THE TIP HAD SEPARATED 2MM DISTAL TO THE DISTAL BALLOON MARKER. THE SEPARATED PORTION OF THE BALLOON, SHAFT AND THE TIP WERE NOT RETURNED AND THE FRACTURE FACE WAS JAGGED. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. SCANNING ELECTRON MICROSCOPY (SEM) INDICATED THE BALLOON FAILURE MAY POSSIBLY BE RELATED TO EXPOSURE CONDITIONS AND OR MATERIAL PROCESSING DISCREPANCY. PARTIAL TEARS WERE OBSERVED NEAR THE RUPTURE OVER THE ENTIRE CIRCUMFERENCE OF THE OUTER SURFACE. THE FAILURE OF THE INNER MEMBER MAY BE ATTRIBUTED TO TEARING AND DAMAGE, POSSIBLY RELATED TO HANDLING/ EXPOSURE CONDITIONS. IN THIS CASE, THE BALLOON WAS INFLATED TO 18 ATM AND THE RATED BURST PRESSURE IS 16 ATM. IT SHOULD BE NOTED THAT THE (B)(6) INFORMATION FOR USE (IFU) STATES: WHEN AN ACCEPTABLE POSITION HAS BEEN OBTAINED, INFLATE THE BALLOON TO ACHIEVE THE DESIRED DILATATION. CAUTION: DO NOT EXCEED THE RATED BURST PRESSURE. HIGHER PRESSURES MAY DAMAGE THE BALLOON OR CATHETER. THUS, IT IS LIKELY THAT THE OVER INFLATION OF THE BALLOON ABOVE THE RATED BURST PRESSURE ALONG WITH INTERACTION WITH THE STENOTIC LESION CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. SUBSEQUENT HANDLING AND ATTEMPT TO REMOVE THE DEVICE FROM THE PATIENT RESULTED IN THE SEPARATION AND THE NEED TO REMOVE THE DETACHED SECTION WITH A SNARE DEVICE. ADDITIONALLY, THERE WAS NO LEAK REPORTED DURING PREPARATION OF THE DEVICE SUGGESTING THERE WAS NO DAMAGE OR LEAK PRESENT PRIOR TO USE. THE REPORTED BALLOON RUPTURE, DETACHMENT, FOREIGN BODY REMOVAL AND ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS BEING USED TO TREAT A STENOTIC ARTERIOVENOUS FISTULA IN THE LEFT ARM. THE BALLOON RUPTURED AT 18 ATMOSPHERES. THE BALLOON SEPARATED AND THE SEPARATED PORTION WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE. NO FURTHER PATIENT EFFECTS WERE REPORTED. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 677381

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention