BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALRUS 087 BALLOON GUIDE CATHETER

    MDR report key: 19969152 · Received August 12, 2024

    Report

    Report Number
    3015614180-2024-00009
    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

    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, RED PROWLWER SELECT + MICRO CATH, TRAXCESS 14 MICRO WIRE, SOLITARE STENT 6X40MM, 4X40MM, ATLAS STENT 4.5MM X 30MM (ICA DISSECTION). PATIENT AND PROCEDURE OUTCOME: THE PATIENT'S TICI SCORE IMPROVED FROM 0 TO 2B.

    Description of Event or Problem · 0

    DESCRIPTION OF COMPLAINT: ICA NON OCCLUSIVE 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. ADDITIONAL INFORMATION ABOUT THE PATIENT: (B)(6), AGE OF PATIENT - 78, GENDER - MALE, 1ST RUN - 17:53, LOCATION OF CLOT - PROX M2 WITH ICA STENOSIS, (B)(6), TOTAL PASS-3, START TICI-0, FINAL TICI SCORE - 2B. PATIENT AND PROCEDURE OUTCOME: THE PATIENT'S TICI SCORE IMPROVED FROM 0 TO 2B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200753 WALRUS 087 BALLOON GUIDE CATHETER CATHETER INTRODUCER DQY Q'APEL MEDICAL INC. 087 BALLOON GUIDE CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other