BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 15298282 · Received August 25, 2022

    Report

    Report Number
    3005168196-2022-00390
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Report Date
    November 5, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2022-00390 1. SECTION G. BOX 3. REPORT SOURCE. H3 OTHER TEXT: PLACEHOLDER.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON (B)(6) 2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "EMBOLISATION OF AN ANEURYSMAL HIGH-FLOW RENAL ARTERIOVENOUS FISTULA IN A PAEDIATRIC PATIENT: SIMULTANEOUS ARTERIAL AND VENOUS APPROACH" (FUNG ET AL. 2022). THE EVENT DATE WAS NOT PROVIDED; HOWEVER, THE ARTICLE WAS PUBLISHED ON (B)(6) 2022 AND DOCUMENTS A SINGLE CASE OF RENAL ARTERIOVENOUS FISTULA (AVF) EMBOLIZATION USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE FIRST FRAMING RUBY COIL (40MM X 60CM) WAS IMPLANTED INTO THE TARGET LOCATION USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE DEPLOYING THE SECOND FRAMING RUBY COIL OF THE SAME SIZE, THE FIRST FRAMING COIL MIGRATED WITH ITS DISTAL PORTION PROTRUDING INTO THE INFRARENAL INFERIOR VENA CAVA (IVC). NEXT, A VASCULAR SHEATH (6F) WAS PLACED INTO THE LEFT COMMON FEMORAL VEIN (CFV) AND THE FIRST FRAMING COIL WAS SNARED USING A NON-PENUMBRA CATHETER. TWO ADDITIONAL RUBY COILS WERE IMPLANTED VIA THE TRANSARTERIAL AND THE TRANSVENOUS MICROCATHETERS SIMULTANEOUSLY. AFTER ACHIEVING A STABLE COIL MASS, MULTIPLE RUBY COILS AND POD PACKING COILS (POD PCS) WERE SUCCESSFULLY IMPLANTED VIA THE TRANSARTERIAL MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446630 RUBY COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female