BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 4276364 · Received November 25, 2014

    Report

    Report Number
    2025587-2014-00942
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    October 30, 2014
    Report Date
    January 26, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. EVALUATION OF THE RETURNED DEVICE CONFIRMED A DETACHED NOSE CONE. THE SEPARATED NOSE CONE DID NOT SHOW ANY NECKING OR ELONGATION ON THE PLUNGER TIP TUBE SHAFT. THERE WERE TINY GOUGE MARKS ON THE CATHETER TABS, ASSOCIATED WITH WEAR FROM THE FRAME LOOPS. THIS MAY BE AN INDICATION THAT THE USER EXPERIENCED DIFFICULTY IN DETACHING THE VALVE FRAME FROM THE DCS TABS, AND MAY HAVE PULLED ON THE DCS TO DETACH THE FRAME, CREATING THE TINY GOUGE MARKS ON THE DCS TABS. THIS MAY HAVE ALSO RESULTED IN THE SEPARATED NOSE CONE, AS THE NOSE CONE WAS REPORTED TO HAVE BEEN MAINTAINED ON THE GUIDEWIRE. A DEFINITIVE CAUSE FOR THE SEPARATED NOSE CONE WAS UNABLE TO BE DETERMINED AS NO ANGIOGRAPHY WAS RETURNED FOR REVIEW OF THE CASE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE DEVICE WAS RECEIVED IN A SEMI-SECURED DIE-CUT CARD. THE DISTAL TIP OF THE PLUNGER WAS NOT ATTACHED TO THE PLUNGER TUBE. THE DISTAL TIP OF THE PLUNGER WAS RECEIVED WITH THE CATHETER. THE HANDLE APPEARED INTACT. THE MICRO KNOB (THUMB WHEEL) RETRACTED AND ADVANCED THE CAPSULE. THE MACRO (CURSOR) MOVED TO FULLY ADVANCE AND RETRACTED POSITIONS AND LOCKED IN PLACE WHEN RELEASED. SEVERAL SMALL KINKS OR TELESCOPING WERE OBSERVED ALONG THE CAPSULE BETWEEN THE PROXIMAL AND DISTAL ENDS. TINY STRESS FRACTURES WERE OBSERVED ALONG THE RADIOPAQUE MARKER BAND ON THE TIP OF THE CAPSULE. A SMALL KINK WAS OBSERVED ON THE RADIOPAQUE MARKER BAND. THE HEAD OF THE PLUNGER APPEARED TO HAVE BEEN DETACHED FROM THE PLUNGER TUBE. THE TIP OF THE PLUNGER TUBE DOES NOT SHOW NECKING OR ELONGATION. TINY GOUGE MARKS ON THE CATHETER TABS APPEARED TO BE ASSOCIATED WITH WEAR FROM THE VALVE FRAME LOOPS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WILL BE RETURNED FOR ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS/INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE DELIVERY CATHETER SYSTEM (DCS) NOSE CONE SEPARATED FROM THE REST OF THE DEVICE, BUT REMAINED ON THE GUIDEWIRE. A SNARE WAS USED TO ENSURE THE NOSECONE REMAINED THE GUIDEWIRE AS THE DCS AND NOSECONE WERE WITHDRAWN INTO THE INTRODUCER SHEATH. THE SHEATH AND NOSECONE WERE THEN REMOVED FROM THE PATIENT. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THERE WAS NO UNUSUAL FORCE NOTED THAT WOULD HAVE SEPARATED THE NOSECONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765138 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C4-18FR 0007185630

    Patients

    Seq Age Sex Outcome Treatment
    1