BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2333774 · Received November 11, 2011

    Report

    Report Number
    2024168-2011-07618
    Event Type
    Malfunction
    Date Received
    November 11, 2011
    Date of Event
    October 18, 2011
    Report Date
    October 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING.)" THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITH BLOOD IN THE INFLATION LUMEN AND IN THE BALLOON, CONSISTENT WITH A LEAK OR RUPTURE WHILE IN THE ANATOMY. THERE WAS NO CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED. THE BALLOON WAS SEPARATED 3.9 CENTIMETERS (CM) DISTAL TO THE PROXIMAL SEAL. THERE WAS A LONGITUDINAL RUPTURE PROXIMAL TO THE SEPARATION FOR A LENGTH OF 3.2 CM. THE INNER MEMBER WAS SEPARATED 3 MILLIMETERS DISTAL TO THE PROXIMAL SEAL. THE FRACTURE FACE WAS STRETCHED AND JAGGED, SUGGESTING AN OVERLOAD OF THE MATERIAL. THE SEPARATED PORTION OF THE BALLOON, INCLUDING THE TIP AND SEPARATED INNER MEMBER WERE NOT RETURNED. THERE WAS A KINK IN THE SHAFT 50 CM DISTAL TO THE STRAIN RELIEF TUBING, POSSIBLY DUE TO HANDLING/PACKAGING THE DEVICE FOR RETURN TO ABBOTT VASCULAR. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON CATHETER WAS RETURNED ADVANCED THROUGH A NON-ABBOTT INTRODUCER SHEATH. THERE WAS A TEAR IN THE TIP OF THE NON-ABBOTT INTRODUCER SHEATH. THERE WERE WRINKLES IN THE INTRODUCER SHEATH SHAFT. THERE WAS NO OTHER DAMAGE NOTED TO THE NON-ABBOTT INTRODUCER SHEATH. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS RESULTS INDICATED THAT THE RADIAL SEPARATION OF THE BALLOON MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. EVIDENCE OF MECHANICAL DAMAGE WAS OBSERVED ON THE OUTER SURFACE/EDGE OF THE BALLOON. THE ORIGIN OF THE LONGITUDINAL RUPTURE COULD NOT BE FOUND ON THE PROXIMAL HALF OF THE BALLOON THAT WAS SUBMITTED TO THE SEM LAB. THE LONGITUDINAL RUPTURE ORIGIN MAY HAVE BEEN LOCATED ON THE DISTAL PORTION OF THE BALLOON SEPARATION WHICH WAS NOT RETURNED. IT MAY BE POSSIBLE THAT THE BALLOON RUPTURE OCCURRED DUE TO INTERACTION WITH LESION CALCIFICATION. THERE WAS NO REPORT OF LEAKS NOTED DURING THE PREPARATION FOR USE, SUGGESTING THAT THE BALLOON DAMAGE LIKELY OCCURRED DURING USE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, SUCH AS INTERACTION WITH SHARP CALCIFICATION, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. ADDITIONALLY, THE MATERIAL SEPARATION APPEARS TO BE THE RESULT OF THE RUPTURED BALLOON MATERIAL INTERACTING WITH THE INTRODUCER SHEATH DURING WITHDRAWAL. REPORTEDLY, THE SEPARATED PORTION OF THE BALLOON REMAINED IN THE SHEATH AND THE SHEATH WAS REMOVED WITH THE SEPARATED SEGMENT OF BALLOON. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN AN AV FISTULA, A 10 X 40 X 80 MM FOX PLUS DILATATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY AND THE BALLOON WAS INFLATED TO 10 ATMOSPHERES FOR 30 SECONDS. A BALLOON RUPTURE OCCURRED AND THE DEVICE WAS REMOVED. DURING REMOVAL, PART OF THE BALLOON SEPARATED AND REMAINED IN THE SHEATH. THE SHEATH WAS REMOVED AND THE SEPARATED SEGMENT OF BALLOON WAS REMOVED. A NEW SHEATH WAS INSERTED INTO THE ANATOMY AND A NON-ABBOTT DILATATION CATHETER WAS ADVANCED AND DILATATION PERFORMED. A NON-ABBOTT STENT GRAFT WAS PLACED AND POST-DILATATION WAS PERFORMED USING AN 8 X 40 MM FOX DILATATION CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. USER FACILITY MEDWATCH RECEIVED REPORTING THE FOLLOWING: "TITLE: XXXXX EVENT DESC: DURING INSERTION OF PTA CATHETER, THE BALLOON BURST RESULTING IN NEED TO PULL OUT SHEATH. AFTER RETRIEVAL OF THE SHEATH, THE PHYSICIAN NEEDED TO MANUALLY RETRIEVE A PIECE OF THE BALLOON. MANUFACTURER RESPONSE FOR PTA CATHETER, FOX PLUS PTA CATHETER (PER SITE REPORTER) MANUFACTURER REPRESENTATIVE CALLED IMMEDIATELY WITH PLANS TO ADDRESS THIS ISSUE. HAS REQUESTED THE DEVICE BE RETURNED TO THEM FOR EVALUATION. HAVE NOT GOTTEN PERMISSION FROM LEGAL TO DO SO. WILL OFFER TO HAVE COMPANY REP EVALUATE DEVICE AT UNIVERSITY OF IOWA HOSPITALS AND CENTERS (UIHC), IF PERMISSION IS DENIED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PTA CATHETER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 737439

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention