BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE FLOPPY II GUIDE WIRE

    MDR report key: 3132308 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03324
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    June 17, 2010
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K060449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE SEPARATED PIECES OF GUIDE WIRE ARE BEING RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED. INVESTIGATION IS NOT YET COMPLETED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION. IT WAS FURTHER REPORTED THAT THE COMPLAINT DEVICE WAS A NON-ABBOTT DEVICE. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED DEVICE REVEALED NO NON-CONFORMANCES. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, NEW INFORMATION RECEIVED FROM THE FRENCH COMPETENT AUTHORITY CONFIRMS THAT THE GUIDE WIRE INVOLVED IN THIS EVENT IS NOT AN ABBOTT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A PROCEDURE TO TREAT THE 1ST DIAGONAL OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A HI TORQUE FLOPPY II GUIDE WIRE WAS USED DURING THE PROCEDURE AND A STENT WAS PLACED. THERE WAS NO REPORTED PROCEDURAL COMPLICATIONS. IN 2012, THE PATIENT UNDERWENT A SECOND PROCEDURE DURING WHICH A FRACTIONAL FLOW RESERVE CATHETER WAS USED ON THE LAD, WITH A GOOD RESULT, NO STENT WAS REQUIRED. NO PROCEDURAL COMPLICATIONS WERE REPORTED. IN (B)(6) 2013, THE PATIENT UNDERWENT A SURGICAL PROCEDURE AT (B)(6) HOSPITAL DURING WHICH FIVE PIECES OF AN UNKNOWN DEVICE (GUIDE WIRE OR CATHETER) WERE FOUND IN THE PATIENT; 3 PIECES WERE EXTRACTED; HOWEVER, 2 PIECES REMAIN IN THE PATIENT AS THEY ARE WELL SECURED IN THE CAROTIDIEN SYPHON. THE PIECES WERE LOCATED AT THE SUBCLAVIAN ARTERY (RIGHT) AND AT THE PRIMITIVE CAROTID ARTERY. IT HAS NOT BEEN DETERMINED IF THE SEPARATED PIECES BELONG TO THE HI TORQUE FLOPPY GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236411 HI-TORQUE FLOPPY II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 0050791

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R