BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK W/COPILOT

    MDR report key: 4343447 · Received December 18, 2014

    Report

    Report Number
    2024168-2014-08275
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BROKEN HANDLE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL 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. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. AN ADDITIONAL (B)(4) UNUSED DEVICES WERE RETURNED AND ANALYSED. ANALYSIS OF THE DEVICES DID NOT SHOW ANY INDICATION OF DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN AN UNSPECIFIED ARTERY. DURING POST-DILATION WITH THE BALLOON CATHETER, WHEN ATTEMPTING TO APPLY NEGATIVE PRESSURE TO DEFLATE THE BALLOON, THE SHAFT OF THE INDEFLATOR BROKE APART IN THE OPERATORS HAND. THIS WAS NOT THE INITIAL INFLATION/DEFLATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. CASE (B)(4) HAS BEEN OPENED TO CAPTURE THE RETURN OF (B)(4) UNUSED/STERILE DEVICES WITH LOT NUMBER 4091301.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE SITE COMMENTED THAT THIS DEVICE ISSUE HAS THE POTENTIAL TO CAUSE SIGNIFICANT INJURY TO THE CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834277 20/30 PRIORITY PACK W/COPILOT ACCESSORY KIT MAV AV-TEMECULA-CT 4091301

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR