BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 11356662 · Received February 21, 2021

    Report

    Report Number
    9681477-2021-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2021
    Date of Event
    January 26, 2021
    Report Date
    March 27, 2021
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    UDI-DI
    08714729326540
    PMA / PMN Number
    K935170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    AMENDING AS DEVICE RECEIVED FOR EVALUATION. THE OBSERVATION MADE DURING THE INVESTIGATION DETERMINED THAT THE RETURNED GUIDEWIRE WAS KINKED CLOSE TO THE DISTAL END. AN OFFSET WAS PRESENT AT THE POINT WHERE THE GUIDEWIRE WAS KINKED. BOTH THE DISTAL AND PROXIMAL JOINTS WERE INTACT PASSING FINGERPULL TEST, WHICH CONFIRMED GUIDEWIRE WAS NOT FRACTURED. NO OTHER DAMAGE WAS NOTED ON THE RETURNED PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AT THIS TIME IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, "EXCESSIVE FORCE USED" AND/OR "IMPROPER USE" MAY HAVE IMPACTED ON THE EVENT AS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: TORN GUIDE (ANOMALY DETECTED DURING USE). ADDITIONAL INFORMATION: 'THE SALE REP RESPONDED WITH THE FOLLOWING: 1. WAS THERE ANY DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE? NO. 2. WAS THERE ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING? NO. 3. WAS THE PRODUCT INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL? YES. 4. WHAT ACTIONS WERE PERFORMED ON THE GUIDEWIRE TO PREPARE THE GUIDEWIRE FOR USE? I DON'T KNOW. 5. WERE ANY PROBLEMS NOTED DURING PREPARATION? NO. 6. WAS UNUSUAL FORCE EVER REQUIRED WHEN USING THE DEVICE? NO. 7. THE LOT NUMBER PROVIDED 5926543 DOES NOT MATCH WITH THE GUIDE STARTER INVOLVED. COULD YOU PLEASE PROVIDE THE STARTER DEVICE BATCH/LOT #? 5926453. 8. THE DEVICE HAS NOT YET BEEN RECEIVED FOR ANALYSIS. I WOULD LIKE TO CONFIRM IF THE DEVICE IS AVAILABLE FOR ANALYSIS? IF YES, WHAT IS THE EXPECTED DATE OF DEVICE TO BE RETURNED TO BSC? IF NO, WHAT IS REASON OF DEVICE NOT AVAILABLE FOR RETURN? DEVICE AVAILABLE AT THE PHARMACY SERVICE / CARRIER DID NOT SHOW UP [?]'

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS PROVIDED FOR ANALYSIS. AS REPORTED BY THE CUSTOMER: "TORN GUIDE (ANOMALY DETECTED DURING USE)''. THERE WAS ADDITIONAL INFORMATION PROVIDED THAT THE GUIDEWIRE WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AT THIS TIME IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION, "EXCESSIVE FORCE USED" AND/OR "IMPROPER USE" MAY HAVE IMPACTED ON THE EVENT AS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: TORN GUIDE (ANOMALY DETECTED DURING USE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253574 STARTER GUIDEWIRE GUIDEWIRE DQX LAKE REGION MEDICAL LIMITED M001491211 5926453 08714729326540

    Patients

    Seq Age Sex Outcome Treatment
    1