BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 2231648 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06086
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON CATHETER WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS RETURNED LOOSELY FOLDED, CONSISTENT WITH BEING INFLATED. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. DURING FUNCTIONAL TESTING, THE REPORTED BALLOON RUPTURE WAS CONFIRMED. A NEW INDEFLATOR FILLED WITH WATER WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED OUT OF A PINHOLE IN THE BALLOON 13 MM DISTAL TO THE PROXIMAL BALLOON MARKER. THERE WAS A RADIAL SCRATCH 2 MM PROXIMAL TO THE PINHOLE. IN THIS CASE, IT IS LIKELY THAT THE BALLOON RUPTURE IS RELATED TO INTERACTION WITH THE CALCIFIED LESION. THE SCRATCH NOTED NEAR THE PINHOLE FURTHER SUGGESTS INTERACTION WITH THE CALCIFICATION. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE DURING THE PROCEDURE, THIS CAN CAUSE THE BALLOON MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE BALLOON. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. A FOX PLUS DEVICE IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FIRST INFLATION OF THE FOX PLUS BALLOON IN A CALCIFIED ABDOMINAL AORTA IT RUPTURED AT 5 ATM. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUES, NOTHING REMAINED IN THE PATIENT. A NEW FOX PLUS BALLOON (SAME SIZE) WAS USED SUCCESSFULLY. FOLLOWING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE AN ATTEMPT WAS MADE TO CLOSE A MILDLY CALCIFIED COMMON FEMORAL ARTERY WITH A PROGLIDE DEVICE. REPORTEDLY, THE DEVICE COULD NOT BE ADVANCED OVER THE WIRE AND A SECOND PROGLIDE NEEDED TO BE USED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL 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 719638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE: CORDISVESSEL CLOSURE: PROGLIDE