BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 2251517 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06368
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 FOUR ADDITIONAL FOXCROSS DILATATION CATHETERS ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. 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 AND CONTRAST IN THE HUB, INFLATION LUMEN AND IN THE BALLOON, CONSISTENT WITH A LEAK OR RUPTURE WHILE IN THE ANATOMY. THE BALLOON WAS RETURNED LOOSELY FOLDED, INDICATING THAT IT HAD BEEN INFLATED. THERE WAS A KINK IN THE SHAFT 9.5 CM PROXIMAL TO THE PROXIMAL SEAL, POSSIBLY DUE TO HANDLING. THERE WERE INDENTATIONS IN THE SHAFT 18 CM PROXIMAL TO THE PROXIMAL SEAL SPORADICALLY FOR A LENGTH OF 5.6 CM. THESE INDENTATIONS ARE CONSISTENT WITH CHATTER MARKS WHICH TYPICALLY OCCUR IF THE SHAFT MEETS RESISTANCE AROUND A TIGHT CURVE OR ANGLE. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. DURING FUNCTIONAL TESTING, A NEW INDEFLATOR FILLED WITH WATER WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED OUT A PINHOLE IN THE BALLOON 2 MM PROXIMAL TO THE DISTAL BALLOON MARKER. SCANNING ELECTRON MICROSCOPY ANALYSIS WAS PERFORMED AND THE RESULTS INDICATE THAT THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. IT IS LIKELY THAT THE BALLOON RUPTURE MAY BE ATTRIBUTED TO INTERACTION WITH THE LESION, AS THERE WERE ALSO 4 ADDITIONAL FOXCROSS CATHETERS REPORTED TO HAVE RUPTURED DURING THIS CASE. ADDITIONALLY, 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 CALCIFICATION, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE BALLOON. 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. 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 HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A LESION IN THE POPLITEAL ARTERY, THE 5 X 40 MM FOXCROSS DILATATION CATHETER WAS ADVANCED INTO THE PATIENT ANATOMY WITHOUT RESISTANCE; HOWEVER THE BALLOON RUPTURED DURING THE THIRD INFLATION AT UNSPECIFIED ATMOSPHERES (ATM) BETWEEN 10-15 ATM. THE DILATATION CATHETER WAS REMOVED FROM THE ANATOMY AND ANOTHER 5 X 40 MM FOXCROSS DILATATION CATHETER WAS ADVANCED AND THE SAME OCCURRED. IT WAS REMOVED AND A THIRD SAME SIZE FOXCROSS DILATATION CATHETER WAS ADVANCED AND RUPTURED DURING THE THIRD INFLATION AT UNSPECIFIED ATMOSPHERES BETWEEN 10-15 ATM. THE DILATATION CATHETER WAS REMOVED AND A FOURTH SAME SIZE FOXCROSS DILATATION CATHETER WAS ADVANCED AND THE SAME OCCURRED. IT WAS REMOVED AND A NEW SAME SIZE FOXCROSS DILATATION CATHETER WAS ADVANCED; HOWEVER, THIS ONE ALSO RUPTURED DURING THE THIRD INFLATION AT UNSPECIFIED ATMOSPHERES BETWEEN 10-15 ATM. IT WAS REMOVED FROM THE ANATOMY, AND A NEW FOXCROSS DILATATION CATHETER WAS ADVANCED AND DILATION WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. 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 724775

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR