BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 11140288 · Received January 8, 2021

    Report

    Report Number
    1820334-2021-00039
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    May 4, 2018
    Report Date
    February 4, 2021
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002341903
    PMA / PMN Number
    K151676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION (B)(6) FROM (B)(6) HOSPITAL IN THE UNITED STATES INFORMED COOK ON (B)(6) 2018 OF AN INCIDENT INVOLVING A RETRACTA DETACHABLE EMBOLIZATION COIL [RPN: MWCER-35-7-10] FROM LOT NUMBER 7141751. ON (B)(6) 2018, DURING A PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE COIL. USING THE PROVIDED TORQUE DEVICE, THE PHYSICIAN TURNED THE TORQUE DEVICE FOR 5-7 MINUTES BEFORE THE COIL RELEASED INTO THE TARGET LOCATION. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY, THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD FOUND THAT PROPER PROCEDURES ARE IN PLACE TO IDENTIFY AND PREVENT THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE RISKS ASSOCIATED WITH THE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NONCONFORMANCES ASSOCIATED WITH THIS DEVICE LOT. A DATABASE SEARCH FOUND ONE ADDITIONAL COMPLAINT REGARDING AN UNRELATED FAILURE MODE ASSOCIATED WITH THIS DEVICE LOT. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. ADDITIONALLY, A REVIEW OF THE PRODUCT LABELING FOR THE DEVICE WAS COMPLETED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING INSTRUCTIONS RELATED TO THE REPORTED FAILURE MODE: INTENDED USE: ¿THE RETRACTA DETACHABLE EMBOLIZATION COIL IS INTENDED FOR ARTERIAL AND VENOUS EMBOLIZATION IN THE PERIPHERAL VASCULATURE.¿ WARNINGS: ¿THE RETRACTA DETACHABLE EMBOLIZATION COIL IS NOT RECOMMENDED FOR USE WITH POLYURETHANE CATHETERS OR CATHETERS WITH SIDEPORTS. IF A CATHETER WITH SIDEPORTS IS USED, THE EMBOLUS MAY LODGE IN THE SIDEPORT OR PASS INADVERTENTLY THROUGH IT. USE OF A POLYURETHANE CATHETER MAY ALSO RESULT IN LODGING OF THE EMBOLUS WITHIN THE CATHETER.¿ PRECAUTIONS: ¿PRIOR TO INTRODUCTION OF THE EMBOLIZATION COIL, FLUSH THE ANGIOGRAPHIC CATHETER WITH SALINE.¿ PRODUCT RECOMMENDATIONS: -¿THE FOLLOWING CATHETERS ARE RECOMMENDED FOR USE WITH RETRACTA DETACHABLE EMBOLIZATION COILS: HNB(R)4.0-35, HNB(R)5.0-35, HNB(R)5.0-38, SCBR-5.0-38, SCBR-4.0-38.¿ INSTRUCTIONS FOR USE: -¿6. UNDER FLUOROSCOPIC VISUALIZATION, SLOWLY ADVANCE THE DELIVERY WIRE UNTIL THE ENTIRE LENGTH OF THE COIL EXITS THE DISTAL END OF THE CATHETER. ENSURE THAT THE JUNCTION REMAINS POSITIONED JUST INSIDE THE CATHETER TIP. NOTE: ADVANCING THE DELIVERY WIRE SLOWLY ALLOWS THE JUNCTION TO BE SEEN MORE EASILY AND REDUCES THE RISK OF DAMAGING IT. NOTE: IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING COIL ADVANCEMENT, DO NOT CONTINUE ADVANCING. RETRACT THE DELIVERY WIRE SLIGHTLY, THEN GENTLY RE-ADVANCE IT. IF THERE IS STILL SIGNIFICANT RESISTANCE, WITHDRAW THE DELIVERY WIRE FROM THE CATHETER AND TRY USING A NEW COIL WITH A SHORTER LENGTH." -¿8. IF THE COIL POSITION IS CORRECT, USE THE TORQUE DEVICE TO TURN THE DELIVERY WIRE COUNTERCLOCKWISE 8-10 TIMES, UNTIL THE COIL DETACHMENT CAN BE EITHER FELT OR VISUALIZED UNDER FLUOROSCOPY.¿ HOW SUPPLIED: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF THE PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE FOR FAILURE WAS TRACED TO COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. IT IS POSSIBLE THAT THE FAILURE COULD HAVE OCCURRED DUE TO IMPROPER HANDLING OF THE DEVICE DURING DEPLOYMENT, DIFFICULT PATIENT ANATOMY, INADEQUATE PRODUCT PLANNING (SIZING), OR PREPARATION FOR USE. IT IS ALSO POSSIBLE THAT THE JUNCTION WAS OUTSIDE OF THE TIP OF THE CATHETER DURING DEPLOYMENT. WITHOUT THE SUPPORT AND STABILITY OF THE CATHETER TIP, IT IS VERY DIFFICULT TO RELEASE THE COIL. KEEPING THE JUNCTION JUST INSIDE THE CATHETER TIP DURING RELEASE IS STATED IN THE IFU. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS A PART OF A REMEDIATION EFFORT REGARDING DIFFICULT DEPLOYMENT OF RETRACTA EMBOLIZATION COILS. UPON REVIEW OF THIS COMPLAINT DUE TO AN OUS REGULATORY INQUIRY, IT WAS DETERMINED THE INITIAL REPORTABILITY ASSESSMENT WAS INCORRECT. FURTHER INVESTIGATION IS BEING CONDUCTED AND A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A RETRACTA DETACHABLE EMBOLIZATION COIL FOR A HEMOSTASIS OF A SPLENIC BLEED. AFTER ADVANCING THE COIL TO THE TARGET LOCATION, IT TOOK AN ESTIMATED 5-7 MINUTES OF TURNING THE TORQUE DEVICE IN ORDER TO RELEASE THE COIL FROM THE DELIVERY WIRE. ULTIMATELY, THE DEVICE WAS SUCCESSFULLY DEPLOYED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34305 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 7141751 10827002341903

    Patients

    Seq Age Sex Outcome Treatment
    1