BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL LP

    MDR report key: 12000398 · Received June 15, 2021

    Report

    Report Number
    3005168196-2021-01328
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 20, 2021
    Report Date
    August 18, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00815948021792
    PMA / PMN Number
    K192955
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 #1 MFR REPORT:3005168196-2021-01328. 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. EVALUATION OF THE RETURNED PACKING COIL LP REVEALED THAT THE PET LOCK WAS SEPARATED, THE PULL WIRE WAS FRACTURED AND RETRACTED OUT OF THE PROXIMAL END OF THE PUSHER ASSEMBLY, AND THE EMBOLIZATION COIL WAS INTACT WITH THE PUSHER ASSEMBLY AND HAD OFFSET COIL WINDS ALONG ITS LENGTH. FURTHER EVALUATION REVEALED THAT THE PULL WIRE WAS IN ITS INITIAL POSITION WITHIN THE PUSHER ASSEMBLY DDT. IF THE PROXIMAL END OF THE PUSHER ASSEMBLY IS INSERTED INTO THE HANDLE, AND THE HANDLE IS REPEATEDLY ACTUATED, DAMAGE SUCH AS A FRACTURED PULL WIRE MAY OCCUR. DUE TO THE DAMAGE, THE DEVICE COULD NOT BE FUNCTIONALLY TESTED; THEREFORE, THE ROOT CAUSE OF THE INABILITY TO DETACH COULD NOT BE DETERMINED. EVALUATION OF THE RETURNED RUBY COIL LP REVEALED THAT THE PUSHER ASSEMBLY MID-JOINT WAS RETRACTED THROUGH THE INTRODUCER SHEATH FRICTION LOCK. IF THIS OCCURS, RESISTANCE MAY BE EXPERIENCED DURING ADVANCEMENT. FORCEFUL ADVANCEMENT AGAINST THIS RESISTANCE LIKELY CONTRIBUTED TO THE PUSHER ASSEMBLY KINKS NEAR THE MID-JOINT. DURING FUNCTIONAL TESTING, THE PUSHER ASSEMBLY MID-JOINT WAS ADVANCED THROUGH THE INTRODUCER SHEATH FRICTION LOCK WITH RESISTANCE, BUT THE INTRODUCER SHEATH COULD NOT ADVANCE ANY FURTHER DUE TO THE KINK NEAR THE MID-JOINT. PENUMBRA COILS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1.3005168196-2021-01327. 2.3005168196-2021-01329. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS, PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE TWO RUBY COIL LPS WOULD NOT ADVANCE FROM THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LPS WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ADVANCED A PACKING COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. SUBSEQUENTLY, THE PACKING COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2021-01327, 3005168196-2021-01329.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS, PACKING COIL LPS, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE FROM THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE OTHER RUBY COIL LP AND PACKING COIL LP. THEREFORE, THE RUBY COIL LPS AND PACKING COIL LP WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896053 RUBY COIL LP HCG, KRD HCG PENUMBRA, INC. RBYLP0315 F100290 00815948021792

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR