BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3953760 · Received July 23, 2014

    Report

    Report Number
    3005168196-2014-00464
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00465, 00466, 00467 AND 00468.

    Additional Manufacturer Narrative · 1

    RESULT: THE PET LOCK IS STILL INTACT ON THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 125.5 CM FROM THE PROXIMAL END OF THE WIRE. THE PC 400 COIL STRETCH RESISTANCE (SR) WIRE WAS FRACTURED AND THE PC 400 COIL WAS DETACHED FROM THE PUSHER ASSEMBLY. THE PROXIMAL CONSTRAINT SPHERE WAS INSIDE THE DISTAL DETACHMENT TIP (DDT) DISTAL DETACHMENT TIP. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT DURING A PROCEDURE, THE FIRST PC 400 COIL HAD DIFFICULTY ADVANCING AND UNINTENTIONALLY DETACHED, BECOMING STUCK IN THE PX SLIM. THE PX SLIM AND THAT PC 400 COIL WERE WITHDRAWN FROM THE PATIENT. TWO OTHER PC 400 COILS FAILED TO ADVANCE THROUGH A SECOND PX SLIM AND ANOTHER MANUFACTURER'S CATHETER. A NEW PX SLIM WAS USED TO COMPLETE THE PROCEDURE. EVALUATION OF THE RETURNED DEVICES REVEALED NO DAMAGE TO THE PX SLIM CATHETERS, BUT THE PC 400 COILS WERE DAMAGED. EVALUATION OF THE FIRST PC 400 COIL CONFIRMED THAT THE PUSHER ASSEMBLY WAS KINKED AT THE PROXIMAL END OF THE WIRE AND THE PC 400 COIL WAS DETACHED FROM THE PUSHER ASSEMBLY. IT APPEARS THAT THE FORCE USED DURING THE RETRACTION OF THE PC 400 COIL AGAINST THE RESISTANCE, EXCEEDED PRODUCT SPECIFICATION. THIS RESULTED IN A BROKEN SR-WIRE. THE SR-WIRE IS USED TO KEEP THE PC 400 COIL INTACT AND ATTACHED TO THE PROXIMAL CONSTRAINT SPHERE, WHICH IS LOADED INTO DISTAL DETACHMENT TIP OF THE PUSHER WIRE. EVALUATION OF THE SECOND PC 400 COIL REVEALED THAT THE PUSHER ASSEMBLY WAS FRACTURED APPROXIMATELY 5.0 CM FROM THE END OF THE WIRE WHERE THE HYPO-TUBE TAB IS LOCATED. THE PC 400 COIL WAS DETACHED FROM THE DDT. THIS UNINTENTIONAL DETACHMENT LIKELY OCCURRED DUE TO THE PULL WIRE RETRACTING AT THE FRACTURE POINT, ALLOWING THE PROXIMAL CONSTRAINT SPHERE TO BECOME DISLODGED. FURTHERMORE, THE DISTAL END OF THE PET LOCK WAS DELAMINATED AND COMPRESSED. THIS DAMAGE LIKELY OCCURRED DUE TO IMPROPER HANDLING DURING USE. IF THE PC 400 COIL WAS ATTEMPTED TO BE REMOVED AGAINST RESISTANCE WHILE GRIPPING ON THE PET LOCK, THIS TYPE OF DAMAGE MAY OCCUR. THE PC 400 COIL WAS NOT RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. EVALUATION OF THE THIRD PC 400 COIL REVEALED THAT THE COIL WAS STILL ATTACHED TO THE PUSHER AND THE PET LOCK WAS STILL INTACT. THE COMPLAINT INDICATED THERE WAS AN ISSUE GETTING THE PC 400 COIL OUT OF THE SHEATH. WHILE DECONTAMINATING THE SECOND PC 400 COIL, IT WAS ADVANCED OUT OF THE INTRODUCER SHEATH WITH SLIGHT FRICTION. AFTER DECONTAMINATION, THE PC 400 COIL WAS RE-INSERTED IN THE SHEATH AND ADVANCED IN AND OUT SMOOTHLY. THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS KINKED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE PC 400 COILS WERE MANIPULATED AT AN ANGLE AGAINST RESISTANCE, IT IS LIKELY THAT DAMAGE WILL OCCUR. IN ADDITION, A 0.025"MANDREL WAS INTRODUCED THROUGH THE HUBS OF BOTH OF THE RETURNED PX SLIM CATHETERS AND ADVANCED DISTALLY OUT THE DISTAL TIP WITHOUT AN ISSUE. THE PX SLIM CATHETERS WERE FUNCTIONAL. THE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. THE CATHETERS ARE 100% VISUALLY INSPECTED. THE PC 400 COILS ARE 100% FUNCTIONAL TESTED DURING INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400 AND A PX SLIM DELIVERY MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING A PENUMBRA COIL 400 AND CONTINUED PULLING ON THE PUSHER WIRE UNTIL THE COIL DETACHED AND REMAINED STUCK IN THE PX SLIM DELIVERY MICROCATHETER. THE PHYSICIAN RETRIEVED THE PX SLIM DELIVERY MICROCATHETER OUT OF THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED COIL WITH A SALINE FLUSH AND A GUIDE WIRE; HOWEVER, WAS UNSUCCESSFUL. THE PX SLIM DELIVERY MICROCATHETER AND THE PENUMBRA COIL 400 WERE REPLACED WITH NEW DEVICES. WHILE DEPLOYING ANOTHER PENUMBRA COIL 400, THE PHYSICIAN LOST ACCESS TO THE TARGET VESSEL AND ATTEMPTED TO RETRACT THE PENUMBRA COIL 400; HOWEVER, THE COIL PARTIALLY DETACHED WITHIN THE ARTERY. THE PHYSICIAN USED THE PUSHER WIRE AND PLACED THE DETACHED PENUMBRA COIL 400 INSIDE THE ARTERY. AFTER DEPLOYING SEVERAL MORE PENUMBRA COILS, THE PHYSICIAN HAD DIFFICULTY UNSHEATHING A PENUMBRA COIL 400 AND COULD NOT ADVANCE IT THROUGH THE HUB OF THE PX SLIM DELIVERY MICROCATHETER. ANOTHER PENUMBRA COIL 400 WAS USED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE PX SLIM DELIVERY MICROCATHETER ALONG WITH ANOTHER MANUFACTURER'S GUIDE WIRE, BUT WAS UNABLE TO ADVANCE IT. THE OPERATION CONTINUED USING A NEW PX SLIM DELIVERY MICROCATHETER. THE PATIENT WAS WELL AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431920 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F32267

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR