BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1994164 · Received February 16, 2011

    Report

    Report Number
    2024168-2011-00937
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE BALLOON CATHETER WAS RETURNED WITH BLOOD IN THE BALLOON AND GUIDE WIRE LUMEN AND NO CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS INSERTED INTO THE PATIENT ANATOMY AND THE BALLOON WAS INFLATED AND RUPTURED. 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 THE 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 (RBP) AND A SAMPLING OF UNITS ARE RUPTURE TESTED PRIOR TO RELEASE FOR USE. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BALLOON PRESSURE AND BALLOON INTEGRITY. DURING DEVICE ANALYSIS A NEW INDEFLATOR WAS USED TO PRESSURIZE THE BALLOON TO RBP OF (20ATMS) AND FLUID WAS OBSERVED LEAKING OUT OF A PINHOLE IN THE BALLOON DISTAL TO THE DISTAL BALLOON MARKER. THERE WERE NO SCRATCHES FOUND AND IT COULD NOT BE DETERMINED IF THE PINHOLE WAS ALONG A CREASE OR FOLD IN THE BALLOON. THE BALLOON CATHETER WAS SENT TO SCANNING ELECTRON MICROSCOPY (SEM) TO PERFORM FURTHER ANALYSIS OF THE BALLOON. THE RESULTS INDICATED THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE REPORTED ANATOMICAL CONDITION WAS HEAVY CALCIFICATION WHICH IN THIS CASE MAY HAVE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. ADDITIONALLY, THE BALLOON DID NOT RUPTURE UNTIL THE THIRD INFLATION. IN THIS CASE, THE REPORTED RUPTURE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS INFLATED THREE TIMES TO 10 ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED DURING THE THIRD INFLATION. THE DEVICE WAS WITHDRAWN WITHOUT FURTHER INCIDENT. A NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. THE EVENT DID NOT CAUSE A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 615084

    Patients

    Seq Age Sex Outcome Treatment
    1