BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NESTER PLATINUM EMBOLIZATION COIL

    MDR report key: 16018543 · Received December 20, 2022

    Report

    Report Number
    1820334-2022-01873
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    June 16, 2022
    Report Date
    December 20, 2022
    Manufacturer
    COOK INC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: PREAMENDMENT. INVESTIGATION ¿ EVALUATION. (B)(4) (NETHERLANDS) INFORMED COOK ON (B)(6) 2022 OF AN INCIDENT THAT OCCURRED ON (B)(6) 2022 INVOLVING AN MWCE-35-14-4-NESTER (NESTER PLATINUM EMBOLIZATION COIL) FROM AN UNKNOWN LOT. IT WAS REPORTED THAT THE USER WAS UNABLE TO ADVANCE THE COIL INTO THE CATHETER. THIS OCCURRED PRIOR TO PATIENT CONTACT SO NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. COOK RECEIVED TWO ELONGATED FRAGMENTS IN A USED AND DAMAGED CONDITION. UPON FURTHER REVIEW OF THE RETURNED DEVICES, IT APPEARS THE RETURNED PRODUCT IS ONE STRETCHED/ELONGATED COIL THAT BECAME SEPARATED. DUE TO THE CONDITION THE DEVICE WAS RETURNED IN, THE OUTER DIAMETER COULD NOT BE ACCURATELY MEASURED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICE. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS ABLE TO IDENTIFY 7 POSSIBLE LOT NUMBERS, 8220549, 8535989, 8603633, 13975221, 14236676, 14388613, AND 14708019. OF THE IDENTIFIED POSSIBLE LOTS (14236676), REVEALED ONE RELEVANT NON-CONFORMANCE FOR ¿SEPARATED¿; HOWEVER THIS STEP IS CHECKED 100% AND ALL NONCONFORMANCE'S HAVE BEEN SCRAPPED. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE POSSIBLE LOT NUMBERS. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [T_CE_NEC_REV4] STATE THE FOLLOWING: "PRECAUTIONS: PRIOR TO INTRODUCTION OF THE EMBOLIZATION COIL, FLUSH THE ANGIOGRAPHIC CATHETER WITH SALINE. INSTRUCTIONS FOR USE: 2. FIRMLY GRASP THE LOADING CARTRIDGE BETWEEN THUMB AND FOREFINGER. INTRODUCE THE METAL END OF THE LOADING CARTRIDGE INTO THE BASE OF THE CATHETER HUB. LOCK LOADING CARTRIDGE ONTO CATHETER HUB BY TURNING LUER LOCK ADAPTER CLOCKWISE. 3. MAINTAINING POSITION OF THE CARTRIDGE, ADVANCE THE STIFF PORTION OF THE WIRE GUIDE INTO THE LOADING CANNULA. PUSH THE COIL INTO THE FIRST 20 TO 30 CM OF THE ANGIOGRAPHIC CATHETER. REMOVE THE WIRE GUIDE AND LOADING CARTRIDGE. 4. WITH THE FLEXIBLE TIP OF THE WIRE GUIDE, ADVANCE THE EMBOLIZATION COIL TO THE TIP OF THE CATHETER. VERIFY POSITION OF THE ANGIOGRAPHIC CATHETER PRIOR TO DEPLOYMENT. 5. DEPLOY THE COIL BY ADVANCING THE WIRE GUIDE PAST THE TIP OF THE CATHETER." BASED ON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. IT IS POSSIBLE THE LOADING CARTRIDGE WAS NOT FULLY TIGHTENED ONTO THE CATHETER; HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION COIL WAS DIFFICULT TO ADVANCE INTO A COMPETITOR'S 0.035 CATHETER. THE USER OBTAINED LARGER COILS TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. DURING INVESTIGATION OF THE RETURNED DEVICE, IT WAS DISCOVERED THE COIL WAS SEPARATED, THUS PROMPTING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024230 NESTER PLATINUM EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 0.035, 100CM COBRA CATHETER (CORDIS)