BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 19632968 · Received June 28, 2024

    Report

    Report Number
    2135147-2024-03114
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 27, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    UDI-DI
    00811806010793
    PMA / PMN Number
    K072313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF RETRACTION PROBLEM AND MATERIAL BENT WAS REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. IN THIS CASE, THE RETURNED DEVICE ANALYSIS CONFIRMED THE REPORTED MATERIAL BENT OF THE DELIVERY SHEATH. ADDITIONALLY, IT WAS OBSERVED THAT THE SHEATH TIP HAD INVAGINATED. THE REPORTED RETRACTION PROBLEM COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE RETURNED CONDITIONS OF THE DEVICE (BENT DEVICE AND SHEATH TIP INVAGINATION). BASED ON THE AVAILABLE INFORMATION, THE REPORTED RETRACTION PROBLEM WAS DUE TO THE REPORTED MATERIAL BENT OF THE DELIVERY SHEATH. HOWEVER, THE CAUSE FOR THE REPORT MATERIAL BENT AND OBSERVED MATERIAL INVAGINATION COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 12 JUNE 2024, A AMPLATZER PATENT DUCTUS ARTERIOSUS (PDA) OCCLUDER (9-PDA- 006 BATCH 8580360) WAS CHOSEN FOR IMPLANT UTILIZING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM (LOT: 9232542). DURING IMPLANTATION, WHEN ATTEMPTING TO RECAPTURE THE DEVICE, THE END OF THE DELIVERY SHEATH BENT AND THE OCCLUDER COULD NOT RECAPTURED. THE DELIVERY SHEATH WAS REPLACED WITH AMPLATZER TORQVUE EXCHANGE SYSTEM 9-EITV08F180/80 (LOT: 8181072) WHICH WAS THEN USED TO RETRACT THE OCCLUDER SUCCESSFULLY. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE STABLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206916 AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL 9232542 00811806010793

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Female 6MM AMPLATZER PDA OCCLUDER