BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSFORM COMPLIANT 4MM X 15MM

    MDR report key: 6153228 · Received December 7, 2016

    Report

    Report Number
    3008881809-2016-00296
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 13, 2016
    Report Date
    March 24, 2017
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    MJN
    PMA / PMN Number
    K122576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE ¿ ADDED, DEVICE EVALUATED BY MFG ¿ CORRECTED, EXPIRATION DATE - ADDED, PRODUCT AVAILABLE TO STRYKER ¿ CORRECTED, RETURNED TO MANUFACTURER ON - CORRECTED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS RETURNED WITHIN THE DISPENSER HOOP. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGES. A 0.0166 INCH PATENCY MANDREL WAS ADVANCED WITHOUT DIFFICULTY. NO OTHER ANOMALIES WERE NOTED. THE REPORTED LEAK COULD NOT BE CONFIRMED DURING ANALYSIS. A DEMONSTRATION 0.014 INCH GUIDE WIRE GUIDEWIRE WAS INTRODUCED AND ADVANCED THROUGH THE CATHETER PROXIMAL END WITH NO RESISTANCE. DURING FUNCTIONAL TESTING, THE BALLOON WAS ADVANCED TO THE DISTAL TIP TO SEAL, WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED AND DEFLATED WITHOUT DIFFICULTY; THERE WERE NO TEARS OR LEAKS NOTED TO THE INFLATED BALLOON. THERE WAS BLOOD NOTED WITHIN THE BALLOON CATHETER WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE INFLATION AND DEFLATION ISSUES DURING THE PROCEDURE. INFORMATION AVAILABLE SUGGESTS THAT THE GUIDE WIRE WAS PULLED BACK IN AN ATTEMPT TO DEFLATE THE DEVICE DURING THE CLINICAL PROCEDURE, WHICH WOULD HAVE ALLOWED BLOOD TO ENTER THE BALLOON CATHETER. BASED ON THE INFORMATION AVAILABLE, CAUSE OF THE REPORTED BALLOON LEAK CANNOT BE DEFINITELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE, THEN INFLATED, BUT COULD NOT BE DEFLATED. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT AFTER PULLING BACK THE GUIDEWIRE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE, THEN INFLATED, BUT COULD NOT BE DEFLATED. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT AFTER PULLING BACK THE GUIDEWIRE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801741 TRANSFORM COMPLIANT 4MM X 15MM CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN STRYKER NEUROVASCULAR CORK 18706660

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNCHRO GUIDEWIRE (STRYKER)