BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER GUIDE WIRES

    MDR report key: 16678221 · Received April 4, 2023

    Report

    Report Number
    2024168-2023-03481
    Event Type
    Injury
    Date Received
    April 4, 2023
    Date of Event
    January 1, 2010
    Report Date
    April 4, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCIDENT INFORMATION WAS REVIEWED; HOWEVER, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD, CORRECTIVE ACTION TRACKING DATABASE REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART/LOT NUMBERS WERE NOT REPORTED. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO REMOVE AND PEELED / DELAMINATED CANNOT BE DETERMINED. ADDITIONALLY, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND TREATMENT, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND EMBOLISM ARE LISTED IN THE HI-TORQUE GUIDE WIRES INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECTS OF CORONARY PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. DATE OF EVENT ESTIMATED. THE UDI NUMBER IS NOT KNOWN AS THE CATALOGUE NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE, IDENTIFYING THE HT WHISPER GUIDE WIRE AND HT BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE. THE STUDY CONTAINED A TOTAL OF 293 PATIENTS UNDERGOING CORONARY BIFURCATION LESIONS WITH JAILED POLYMER JACKETED GUIDE WIRES (PGW) THAT WAS INVESTIGATING THE RELATIONSHIP BETWEEN WITH PROCEDURAL MYOCARDIAL INFRACTION (PMI) AFTER THE PROCEDURES WERE COMPLETED. TWENTY THREE PATIENTS WERE NOTED TO DEVELOP PMI. THE MOST COMMON PGW TO BECOME STUCK WAS THE HT WHISPER GUIDE WIRE THAT LEAD TO DIFFICULTY IN REMOVING AND POLYMER SHEARING. THE POLYMER SHEARING IS BELIEVED TO LEAD TO EMBOLIZATION. THE STUDY CONCLUDED THAT JAILED PGW MAY BE ASSOCIATED WITH THE HIGHER RISK OF PMI. MULTIPLE NON PGW GUIDE WIRES WERE MENTIONED FOR STRUCTURAL DAMAGE INCLUDING BMW ALONG WITH OTHER NON-ABBOTT GUIDE WIRES; HOWEVER, IT WAS NOT SPECIFY THAT THE BMW HAD DAMAGED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. ADDITIONAL INFORMATION CAN BE FOUND IN THE ATTACHED ARTICLE "JAILING POLYMER JACKETED GUIDE-WIRES DURING BIFURCATION CORONARY INTERVENTIONS IS ASSOCIATED WITH PROCEDURAL MYOCARDIAL INFARCTION". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404765 HI-TORQUE WHISPER GUIDE WIRES GUIDE WIRE DQX ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other