BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 3250943 · Received July 29, 2013

    Report

    Report Number
    2024168-2013-04725
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE LEAK WAS UNABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THE FOX SV PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER INSTRUCTIONS FOR USE (IFU) STATES: FILL AN INFLATION DEVICE OR A SYRINGE WITH THE DILUTED CONTRAST MEDIUM, CONNECT TO THE INFLATION PORT OF LURE. INJECT DILUTED CONTRAST MEDIUM TO PARTIALLY INFLATE THE BALLOON. DEFLATE THE BALLOON BY DRAWING BACK ON THE SYRINGE PLUNGER, THEREBY DRAWING THE AIR BUBBLES FROM THE BALLOON INTO THE SYRINGE. REPEAT STEPS UNTIL ALL OF THE AIR IN THE BALLOON HAS BEEN DISPLACED BY THE DILUTED INFLATION MEDIUM.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: 0.014 AGOSALXS0.8, THERAPY DATE: (B)(6) 2013. GUIDE CATH: SHEATHLESS, THERAPY DATE: (B)(6) 2013. (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT FILING, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DEVICE WAS PREPPED INSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PREPARATION OF FOX SV BALLOON INSIDE THE ANATOMY, WHEN NEGATIVE PRESSURE WAS APPLIED USING AN INDEFLATOR, AIR CAME INTO THE DEVICE. IT WAS CONFIRMED THAT CONTRAST MEDIUM LEAKED IN THE ANATOMY. NO ADVERSE PATIENT HEALTH IMPACT WAS REPORTED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353307 FOX SV PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 815422

    Patients

    Seq Age Sex Outcome Treatment
    1