BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK W/COPILOT

    MDR report key: 3017929 · Received March 22, 2013

    Report

    Report Number
    2024168-2013-01666
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INDEFLATOR WAS RETURNED FOR ANALYSIS AND THERE WERE NO LEAKS NOTED, THE COMPLAINT STOPCOCK WAS NOT RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE ACTUAL STOPCOCK COULD NOT BE COMPLETED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED INDEFLATOR, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (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 RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KISSING BALLOON TECHNIQUE (KBT) PROCEDURE, DURING WHICH, TWO UNSPECIFIED BALLOON CATHETERS WERE CONNECTED TO THIS SINGLE THREE-WAY STOPCOCK OF THE 20/30 PRIORITY PAK. BOTH OF THE BALLOON CATHETERS WERE CONNECTED TO THE STOPCOCK AND PRESSURE WAS APPLIED TO BOTH OF THE BALLOON CATHETERS AT ONCE WHEN LEAKAGE WAS OBSERVED FROM AROUND THE STOPCOCK. IT IS COULD NOT BE CONFIRMED FROM EXACTLY WHERE THE LEAKAGE WAS OBSERVED. IT COULD HAVE BEEN FROM THE STOPCOCK ITSELF OR FROM THE CONNECTION BETWEEN THE BALLOON CATHETERS AND THE STOPCOCK. THERE WAS NO REPORT OF ANY ANOMALY NOTED TO THE INDEFLATOR USED IN THE CASE BEFORE KBT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119547 20/30 PRIORITY PACK W/COPILOT ACCESSORY KIT MAV AV-TEMECULA-CT 2112801

    Patients

    Seq Age Sex Outcome Treatment
    1