BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALRUS 087 BALLOON GUIDE CATHETER

    MDR report key: 19969158 · Received August 12, 2024

    Report

    Report Number
    3015614180-2024-00013
    Event Type
    Injury
    Date Received
    August 12, 2024
    Report Date
    August 12, 2024
    Manufacturer
    Q'APEL MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K192525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS OBSERVED DURING A REVIEW OF CLINICAL DATA COLLECTED FOR POST-MARKET SURVEILLANCE OF WALRUS STROKE CASES IN THE UK. THE PROCEDURE DATE IS UNKNOWN. THE ATTENDING PHYSICIAN WAS ASKED FOR FOLLOW UP AND BASED ON HIS RECOLLECTION THE COMPLICATIONS WERE RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION RELATED TO THE CASE OR DEVICE WAS ABLE TO BE OBTAINED. Q'APEL MEDICAL HAS MADE GOOD FAITH EFFORTS BUT HAVE BEEN UNSUCCESSFUL (AT THE TIME OF SUBMISSION) IN OBTAINING ADDITIONAL INFORMATION RELATED TO THE CASE INCLUDING DATE OF PROCEDURE. 8 FR. SHORT SHEATH; SOFIA+ ASPIRATION CATH; POWER SELECT + MICRO CATH; SYNCHRO 14 MICRO WIRE; ET III 5MM X 37MM STENT; PATIENT AND PROCEDURE OUTCOME: THE PATIENT'S TICI SCORE IMPROVED FROM 0 TO 3.

    Description of Event or Problem · 0

    DESCRIPTION OF COMPLAINT: NON FLOW LIMITING MID ICA DISSECTION. THE EVENT WAS OBSERVED DURING A REVIEW OF CLINICAL DATA COLLECTED FOR POST-MARKET SURVEILLANCE OF WALRUS STROKE CASES IN THE UK. THE PROCEDURE DATE IS UNKNOWN. THE ATTENDING PHYSICIAN WAS ASKED FOR FOLLOW UP AND BASED ON HIS RECOLLECTION THE COMPLICATIONS WERE RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION RELATED TO THE CASE OR DEVICE WAS ABLE TO BE OBTAINED. Q'APEL MEDICAL HAS MADE GOOD FAITH EFFORTS BUT HAVE BEEN UNSUCCESSFUL (AT THE TIME OF SUBMISSION) IN OBTAINING ADDITIONAL INFORMATION RELATED TO THE CASE INCLUDING DATE OF PROCEDURE. (B)(6), AGE OF PATIENT - 45, GENDER - FEMALE, 1ST RUN - 17:25, LOCATION OF CLOT - TERMINAL ICA. (B)(6), TOTAL PASS-1, START TICI-0, FINAL TICI SCORE - 3. PATIENT AND PROCEDURE OUTCOME: THE PATIENT'S TICI SCORE IMPROVED FROM 0 TO 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200759 WALRUS 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER DQY Q'APEL MEDICAL INC. 087 BALLOON GUIDE CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other