BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 1810390 · Received August 20, 2010

    Report

    Report Number
    2135147-2010-00132
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 20, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K072313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DTV180 (SHEATH, DILATOR, LOADER, DELIVERY CABLE AND HEMOSTASIS VALVE) WAS RETURNED TO AGA MEDICAL WITH THE DISTAL TIP OF THE SHEATH MISSING. FOLLOWING DECONTAMINATION, THE PORTION OF THE SHEATH DISTAL OF THE INNER LINER WAS MISSING AND HAD AN APPEARANCE OF HAVING BEEN TORN AWAY. REVIEW OF THE IMAGES BY AGA'S PRINCIPAL RESEARCH AND DEVELOPMENT SCIENTIST RESULTED IN THE FOLLOWING FINDINGS: IT IS CLEAR FROM THE CINE IMAGING THAT A SHORT CIRCULAR SEMI-RADIOPAQUE HOLLOW OBJECT MOVED FROM THE PROXIMAL END OF THE DEVICE INTO THE DISTAL PULMONARY ARTERY IMMEDIATELY AFTER THE DELIVERY CABLE DETACHED FROM THE DEVICE END SCREW. THE DENSITY OF THE MIGRATED OBJECT WAS SIMILAR TO THE DELIVERY SHEATH. THEREFORE, THE CIRCULAR HOLLOW OBJECT THAT MIGRATED WAS DETERMINED TO BE A PORTION OF THE DELIVERY SHEATH TIP, WHICH SEPARATED FROM THE SHEATH. ALTHOUGH THE CAUSE CANNOT BE CONCLUSIVELY DETERMINED, THE MOST LIKELY CAUSE IS DUE TO THE RECAPTURE OF THE DEVICE, WHICH FOLDED OVER THE TIP OF THE SHEATH WHEN THE DEVICE WAS RECAPTURED. THE FOLDED TIP THEN SEPARATED FROM THE SHEATH WHEN THE DEVICE WAS REDEPLOYED. ALTHOUGH THE FOLDING OVER OF THE SHEATH TIP IS NOT RARE WHEN PERFORMING A DEVICE RECAPTURE, ESPECIALLY WHEN THE DEVICE IS RECAPTURED WITH A HIGH PULLING FORCE OR WITH MULTIPLE RECAPTURES, THE SEPARATION OF THE SHEATH TIP IS RARE. OUR INVESTIGATION WAS ABLE TO CONFIRM THE PERFORMANCE DESCRIBED IN THE FIELD. WE HAVE FORWARDED THIS INFORMATION ONTO OUR MANUFACTURING ENGINEERING AND PROCESS DEVELOPMENT TEAMS FOR ADDITIONAL REVIEW. AGA MEDICAL HAS ALSO RECENTLY REVIEWED THE SHEATH TIP MANUFACTURING PROCESS AND IMPLEMENTED ADDITIONAL INSPECTIONS AND AUTOMATED PROCEDURES TO ENSURE HIGHER QUALITY SHEATH TIPS.

    Description of Event or Problem · 1

    TO SUMMARIZE THIS EVENT, A PROCEDURE CLOSING A FONTAN FENESTRATION WITH A 4MM AMPLATZER SEPTAL OCCLUDER (ASO) USING A 6F AMPLATZER TORQVUE 180 DEGREE DELIVERY SYSTEM (DTV180) WAS PERFORMED. DURING LOADING AND PREPARATION OF THE ASO, THERE WERE NO UNUSUAL EVENTS. THE ASO WAS PLACED IN THE DEFECT AND INITIALLY DID NOT RECAPTURE CORRECTLY. THE RIGHT ATRIAL DISC AND WAIST OF THE ASO WAS RETRACTED INTO THE DTV180 AND REDEPLOYED, AT WHICH TIME, THE ASO WAS POSITIONED CORRECTLY. THE ASO WAS RELEASED AND UPON RELEASE, AN OBJECT WAS SEEN TO TRAVEL FROM THE END OF THE DELIVERY CABLE INTO THE DISTAL PULMONARY ARTERY (PA). THE OBJECT WAS CLEARLY VISIBLE ON FLUOROSCOPY IN THE DISTAL PA. BECAUSE OF THE RISK ASSOCIATED WITH RETRIEVING THE DEVICE FROM THE PA AND THE POTENTIAL FOR PERFORATION, THE OBJECT IN QUESTION WAS LEFT IN THE PATIENT. THE PATIENT HAS EXHIBITED NO ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER TORQVUE DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV06F180/80 0907022385

    Patients

    Seq Age Sex Outcome Treatment
    1