BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6386527 · Received March 8, 2017

    Report

    Report Number
    3002808486-2017-00716
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Date of Event
    February 24, 2017
    Report Date
    February 24, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). A1) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A2) UNKNOWN AS INFORMATION WAS NOT PROVIDED. A4) UNKNOWN AS INFORMATION WAS NOT PROVIDED. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K): K063619. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION OF RETURNED PRODUCT FOUND ABOUT 2.5 COIL LOOPS (OUT OF 4) OF THE PROXIMAL COIL END TO BE ELONGATED. THE PART NOT ELONGATED IS ENTANGLED IN FIBER MATERIAL. FROM THE INVESTIGATION OF THE DELIVERY WIRE IT IS FOUND THAT THE MOST PROXIMAL PART OF THE COIL IS BROKEN OFF AND STILL ATTACHED TO THE DELIVERY WIRE. FOREIGN MATTER IS FOUND SURROUNDING THE JUNCTION BETWEEN THE BROKEN OFF COIL PART AND THE DELIVERY WIRE. IT IS NOT POSSIBLE TO UNSCREW THE COIL PART FROM THE DELIVERY WIRE, AND THE FOREIGN MATTER IS MOST LIKELY CAUSING THIS. THE FOREIGN MATTER IS BELIEVED TO BE SOLIDIFIED CONTRAST LIQUID. IMMERSING THE JUNCTION IN WATER FOR A COUPLE OF MINUTES DOES NOT DISSOLVE THE FOREGIN MATTER, AND IT IS STILL NOT POSSIBLE TO UNSCREW THE PARTS FROM EACH OTHER. THE ELONGATED PART OF THE COIL FOUND AT PRODUCT INVESTIGATION SEEMS TO MATCH THE PART OF THE COIL THAT, ACCORDING TO THE EVENT DESCRIPTION, WAS NOT DEPLOYED BEFORE THE REPOSITIONING ATTEMPT. THE PART WAS THEREFORE INSIDE THE CATHETER WHEN THE PHYSICIAN WITHDREW THE DELIVERY WIRE. THE DISTAL COIL PART MUST HAVE BEEN STUCKED AT THE CATHETER END, WHILE THE PROXIMAL COIL END THEN WAS ELONGATED BY THE WITHDRAWAL. WHY REPOSITIONING WAS NEEDED IS UNKNOWN, BUT THE PRODUCT COMBINATION IS NOT DESIGNED / INTENDED FOR REPOSITIONING. THE ROOT CAUSE OF THE EVENT IS THEREFORE CONCLUDED TO BE THE END USER NOT FOLLOWING INSTRUCTIONS. THE SOLIDIFICATION OF CONTRAST LIQUID ON THE JUNCTION BETWEEN COIL AND DELIVERY WIRE IS LIKELY DUE TO A PROLONGED PROCEDURE. THE PRESENCE OF THIS FOREING MATTER IS NOT BELIEVED TO HAVE PLAYED A PART IN THE ROOT CAUSE, BUT INSTEAD IS SECONDARY TO THE INITIAL PROBLEMS ENCOUNTERED. TO ADDRESS THE ISSUE, THE IFU BOTH PRECAUTIONS AND INSTRUCTS THAT IF DIFFICULTIES OCCUR WHEN DETACHING THE EMBOLIZATION COIL, OR IF RESISTANCE IS FELT WHEN WITHDRAWING THE DELIVERY WIRE, WITHDRAWAL OF THE DELIVERY WIRE MUST NOT BE ATTEMPTED. INSTEAD, THE GUIDING CATHETER AND THE DELIVERY WIRE WITH THE COIL MUST BE REMOVED SIMULTANEOUSLY IN ORDER TO REPLACE THE WHOLE SYSTEM. THE IFU ALSO PROVIDES THE ADDITIONAL INFORMATION THAT IN CASE OF MISPLACEMENT OR INADVERTENT DETACHMENT OF A COIL, THE VASCULAR RETRIEVAL FORCEPS, ORDER NUMBER PREFIX VRF-, CAN BE USED FOR RETRIEVAL OF THE COIL THROUGH THE SHEATH. AS SUCH, NO UPDATE TO THE IFU IS FOUND NECESSARY BASED ON THE INFORMATION IN THIS RECORD. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. IT IS NOTED THAT THE EVENT DID NOT HARM THE PATIENT AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW DEVICE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ACCESS WAS GAINED FROM RIGHT FEMORAL AREA TO PERFORM EMBOLIZATION OF PDA. FIRST 5 FR. ANGIOGRAPHIC CATHETER WAS INSERTED, THEN COMBINED DEVICE OF IMWCE-3-PDA4 AND TDS-110-PDA WERE ADVANCED INTO THE TARGET LESION. THE COIL WAS ADVANCED THROUGH PDA TO PA AND 1.5 LOOPS HAS BEEN PLACED AT PA. TO CHANGE THE POSITION OF THE COIL WITHIN PA, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL INTO THE CATHETER, HOWEVER, IT COULD NOT. AND, THE COIL GOT DETACHED FROM THE DELIVERY WIRE AT UNINTENDED AREA. GOOSE NECK SNARE (COVIDIEN) WAS INSERTED FROM FEMORAL VEIN AND ADVANCED THROUGH PDA TO REMOVE THE COIL AT AORTIC ARCH. ANOTHER SETS OF IMWCE AND TDS WERE USED INSTEAD TO COMPLETE THE PROCEDURE. AFTER PROCEDURE, IT WAS CONFIRMED THAT THE THREAD OF THE COIL AND THE THREAD OF THE DELIVERY WIRE BECAME "STRETCHED". PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ACCESS WAS GAINED FROM RIGHT FEMORAL AREA TO PERFORM EMBOLIZATION OF PDA. FIRST 5 FR. ANGIOGRAPHIC CATHETER WAS INSERTED, THEN COMBINED DEVICE OF IMWCE-3-PDA4 AND TDS-110-PDA WERE ADVANCED INTO THE TARGET LESION. THE COIL WAS ADVANCED THROUGH PDA TO PA AND 1.5 LOOPS HAS BEEN PLACED AT PA. TO CHANGE THE POSITION OF THE COIL WITHIN PA, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL INTO THE CATHETER, HOWEVER, IT COULD NOT. AND, THE COIL GOT DETACHED FROM THE DELIVERY WIRE AT UNINTENDED AREA. GOOSE NECK SNARE (COVIDIEN) WAS INSERTED FROM FEMORAL VEIN AND ADVANCED THROUGH PDA TO REMOVE THE COIL AT AORTIC ARCH. ANOTHER SETS OF IMWCE AND TDS WERE USED INSTEAD TO COMPLETE THE PROCEDURE. AFTER PROCEDURE, IT WAS CONFIRMED THAT THE THREAD OF THE COIL AND THE THREAD OF THE DELIVERY WIRE BECAME STRETCHED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170104 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention