BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 4073014 · Received September 9, 2014

    Report

    Report Number
    2024168-2014-05774
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 21, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR SEPARATIONS FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS RETAINED BY THE HOSPITAL. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THERE WAS NO RESISTANCE FELT DURING REMOVAL OF THE GUIDE WIRE. PRIOR TO SURGERY, THE PATIENT WAS STABILIZED WITH EMERGENCY CORONARY INTERVENTION DUE TO THE LEFT MAIN OCCLUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE FIRST DIAGONAL ARTERY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS POSITIONED AS A SECOND GUIDE WIRE IN THE ANTERIOR DESCENDING ARTERY. AT THE END OF THE PROCEDURE, DURING RETRIEVAL OF THE BMW GUIDE WIRE, THE GUIDE WIRE SEPARATED INTO TWO PIECES. THE SEPARATED PIECE WAS ABLE TO BE RETRIEVED SURGICALLY; HOWEVER, RETRIEVAL OF THE PIECE OF GUIDE WIRE CAUSED A THROMBOLIZATION OF THE COMMON TRUNK THAT REQUIRED TREATMENT WITH A CORONARY ARTERY (4) BYPASS PROCEDURE. THE PATIENT IS ALIVE, BUT WITH AN EJECTION FRACTION OF 20%. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553330 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 4061371

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S