BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 10950023 · Received December 4, 2020

    Report

    Report Number
    1820334-2020-02245
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 20, 2020
    Report Date
    January 13, 2021
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002341996
    PMA / PMN Number
    K151676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D10 ¿ PRODUCT RECEIVED ON: 03DEC2020. INVESTIGATION ¿ EVALUATION. (B)(6) HOSPITAL IN THE UNITED STATES INFORMED COOK OF TWO INCIDENTS INVOLVING A RETRACTA DETACHABLE EMBOLIZATION COIL. ON (B)(6)2020 DURING A PROCEDURE AN ANGIODYNAMIC SOFT CATHETER OF AN INNER DIAMETER OF .038¿ WAS PLACED IN THE PATIENT. A RETRACTA COIL FROMA DIFFERENT LOT WAS ATTEMPTED TO BE PLACED IN THE PATIENT. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE COIL WITHIN THE CATHETER. THE COIL DID NOT EXIT THE DISTAL TIP OF THE CATHETER AND WAS STUCK TOWARDS THE DISTAL END OF THE CATHETER. THIS WAS VERIFIED MULTIPLE TIMES WITH FLUOROSCOPY. THE RETRACTA COIL WAS REMOVED FROM THE PATIENT. NUJ B EXT, A SECOND RETRACTA COIL FROM THE COMPLAINT LOT NUMBER WAS ATTEMPTED TO BE PLACED IN THE PATIENT. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE COIL SYSTEM AND PULLING BACK ON THE SYSTEM TO RETRACT THE COIL INTO THE DELIVERY SYSTEM. THE COIL BECAME STUCK WITHIN THE CATHETER. THE PHYSICIAN WAS FINALLY ABLE TO PULL THE DELIVERY SYSTEM OUT FROM THE CATHETER. A THIRD COIL FROM AN UNKNOWN LOT WAS ATTEMPTED TO BE PLACED IN THE PATIENT. DURING ADVANCEMENT OF THE DELIVERY SYSTEM THROUGH THE CATHETER, THE DELIVERY SYSTEM BECAME STUCK WITHIN THE CATHETER. THE DELIVERY SYSTEM WAS REMOVED TO FIND THE SECOND COIL WITHIN THE CATHETER. NO TORQUE DEVICE WAS USED ON THE SECOND COIL, HOWEVER IT STILL DEPLOYED WITHIN THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT. THE THIRD COIL WAS THEN USED AND COULD SUCCESSFULLY BE PLACED IN THE PATIENT. THERE WERE NO FURTHER COMPLICATIONS DURING THE PROCEDURE. 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, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION, AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED WITH BIOMATTER PRESENT. THE DELIVERY WIRE COULD NOT BE ADVANCED OR REMOVED FROM THE LOADING CARTRIDGE. A COMPETITOR'S CATHETER WAS RECEIVED. THE CATHETER IS A 5FR WITH A CURVE ON THE DISTAL END. THE INNER DIAMETER OF THE CATHETER MEASURED TO BE .045" WITHOUT RESISTANCE AND .046" WITH RESISTANCE. A .035" WIRE GUIDE WAS INSERTED INTO THE CATHETER'S HUB AND RESISTANCE WAS MET AT THE DISTAL END OF THE CATHETER. THE END OF THE CATHETER WAS CUT TO FIND THE COIL. THE COIL WAS PULLED OUT. THE COIL IS PARTLY STRAITENED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT LOT AND RELEVANT SUB-ASSEMBLY LOTS RECORDED ON RELATED NON-CONFORMANCE THAT AFFECTED ONE DEVICE WITH A DISPOSITION OF SCRAPPED. THERE IS A 100% QC INSPECTION FOR THIS NON-CONFORMANCE PRIOR TO RELEASE. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE DEVICE LOT. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO ADDITIONAL COMPLAINTS FROM THE SAME LOT, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT¿S INSTRUCTIONS FOR USE [IFU], ¿RETRACTATM DETACHABLE EMBOLIZATION COILS¿ [T_MWCER_REV5], PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 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." NOTE: DO NOT TURN THE DELIVERY WIRE COUNTERCLOCKWISE DURING ADVANCEMENT; THE COIL MAY BE UNINTENTIONALLY DETACHED.¿ ¿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.¿ THE CATHETER RETURNED HAD A DISTAL CURVE AND THE INNER DIAMETER MEASURED TO BE .045-.046¿. THE CUSTOMER SAID THE INNER DIAMETER OF THE CATHETER WAS .038¿. HOWEVER, THAT IS MOST LIKELY THE WIRE GUIDE¿S OUTER DIAMETER USED DURING THE PROCEDURE. THE IFU INSTRUCTS THE USER ¿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.¿ EVEN THOUGH THE CUSTOMER USED A 5FR CATHETER AND THE IFU ONLY HAS RECOMMENDED CATHETERS. THE LARGER INNER DIAMETER OF THE CATHETER AND THE CURVE AT THE DISTAL TIP LIKELY CAUSED THE ISSUES EXPERIENCED WITH ADVANCING AND REMOVING THE COIL AND THE PREMATURE DEPLOYMENT OF THE COIL WITHIN THE DISTAL TIP OF THE CATHETER. BASED ON THE INFORMATION PROVIDED, INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, THE INVESTIGATION CONCLUSION FOR THIS COMPLAINT IS CAUSE TRACED TO THE USER FOR AN UNINTENDED USE ERROR. 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 INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE COIL IN THE TARGET SITE OF THE HYPERGASTRIC ARTERY, BUT "THE COIL GOT STUCK AT THE CANNULA" AND WOULD NOT COME OUT OF THE COIL DELIVERY SYSTEM. THE PHYSICIAN THEN PULLED THE COIL DEVICE OUT OF THE CATHETER. UPON ATTEMPTED DEPLOYMENT OF THE REPLACEMENT COIL, IT WAS DETERMINED THAT THE COIL HAD DEPLOYED IN THE CATHETER WITHOUT USE OF THE TORQUE DEVICE. THE CATHETER WAS REMOVED AND THE THIRD COIL WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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
    1411927 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 13218806 10827002341996

    Patients

    Seq Age Sex Outcome Treatment
    1