BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    WALRUS 087 BALLOON GUIDE CATHETER

    MDR report key: 19224693 · Received May 1, 2024

    Report

    Report Number
    3015614180-2024-00003
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    September 22, 2023
    Report Date
    March 8, 2024
    Manufacturer
    Q'APEL MEDICAL
    Product Code
    DQY
    UDI-DI
    00857545008028
    PMA / PMN Number
    K192525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: UNABLE TO DETERMINE ROOT CAUSE. THE INFORMATION PROVIDED TO Q'APEL DOES NOT STATE THAT A PRODUCT MALFUNCTION OCCURRED. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT THERE IS NOT ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE DEVICE PROBLEM. FG 00100-01, LOT FG220817J-02 WAS NOT RETURNED TO Q'APEL.

    Description of Event or Problem · 0

    RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE EU MARKET (GERMANY) ON (B)(6) 2023. Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON (B)(6) 2023. Q'APEL MEDICAL FILED AN MIR REPORT ON 11/10/2023. REASON FOR COMPLAINT: DISSECTION AFTER USING WALRUS IN AN EMAIL FROM (B)(6) DATED 10/31/2023: "DISSECTION AFTER USING WALRUS" "M2 CLOSURE ON THE LEFT. S-SHAPED ELONGATION OF PROXIMAL ACI, INSURMOUNTABLE WITH WALRUS, AFTER EXTRACTION V.A. DISSECTION (NOT HEMODYN. EFFECTIVE). INFORMATION WAS COMMUNICATED TO Q'APEL QUALITY ON 10/31/2023. UNCLEAR, AT THE TIME OF COMPLAINT OPEN DATE, IF THE PATIENT REQUIRED MEDICAL INTERVENTION. Q'APEL PERSONNEL HAVE MADE THREE ATTEMPTS TO REQUEST FOR DETAILED INFORMATION REGARDING THE INCIDENT. DATA REGARDING THE INCIDENT WILL NOT BE COLLECTED BY THE DOCTOR ACCORDING TO THE EMAIL FROM THE Q'APEL SALES REPRESENTATIVE DATED ON 11/02/2023. CONCLUSION: UNABLE TO DETERMINE ROOT CAUSE. THE INFORMATION PROVIDED TO Q'APEL DOES NOT STATE THAT A PRODUCT MALFUNCTION OCCURRED. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT THERE IS NOT ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE DEVICE PROBLEM. FG 00100-01, LOT FG220817J-02 WAS NOT RETURNED TO Q'APEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160622 WALRUS 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER DQY Q'APEL MEDICAL 087 BALLOON GUIDE CATHETER FG220817J-02 00857545008028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other