BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 24433932 · Received February 24, 2026

    Report

    Report Number
    2135147-2026-01129
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    UDI-DI
    00811806010793
    PMA / PMN Number
    K072313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NA. IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF BLEEDING WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL DEFINED MANUFACTURING SPECIFICATIONS. THERE WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. BASED ON THE AVAILABLE INFORMATION, THE CAUSE FOR THE REPORTED BLEEDING IS LIKELY RELATED TO RECURRENT SHEATH EXCHANGES, HOWEVER THIS COULD NOT BE DETERMINED. AN UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES, AS A BLOOD TRANSFUSION WAS PERFORMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING, DESIGN, OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 5MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE SIZE DID NOT MATCH THE LESION. A NEW 6MM AMPLATZER DUCT OCCLUDER AND 7F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV) WERE CHOSEN, BUT THE SIZE DID NOT MATCH THE LESION. A NEW 6MM AMPLATZER MUSCULAR VSD OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED USING THE 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THE CLOSURE DONE WITH MANUAL COMPRESSION. AFTER PROCEDURE, A MINOR BLEEDING WAS NOTED DUE TO MULTIPLE SHEATH EXCHANGES. A BLOOD TRANSFUSION WAS PERFORMED. A TOTAL OF 376 IU OF HEPARIN (226U, 50U, 100U) WERE GIVEN TO TARGET AN ACTIVATED CLOTTING LEVELS (ACT) >250. MEASURED ACTS WERE 252, 211, 197 AND 247. THE PRE-PROCEDURAL INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.0 AND WAS 1.1 POST-PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED AND FULLY RECOVERED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50627 AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL 9-ITV07F180/80 9237944 00811806010793

    Patients

    Seq Age Sex Outcome Treatment
    1