BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 11476975 · Received March 12, 2021

    Report

    Report Number
    1820334-2021-00935
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    March 1, 2021
    Report Date
    January 28, 2022
    Manufacturer
    COOK INC
    Product Code
    KRD
    UDI-DI
    10827002342023
    PMA / PMN Number
    K151676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: (B)(6) HOSPITAL (UNITED STATES) INFORMED COOK ON (B)(6) 2021 THAT A COIL UNINTENTIONALLY DETACHED FROM THE DELIVERY WIRE, WHILE USING A MWCER-35-14-16 (RETRACTA DETACHABLE EMBOLIZATION COIL) FROM LOT 9871982. THE COIL WAS ADVANCED THROUGH A 5FR CATHETER TO TREAT A GASTRODUODENAL ARTERY (GDA) ANEURYSM VIA THE SUPERIOR MESENTERIC ARTERY (SMA). DURING DEPLOYMENT THE COIL UNINTENTIONALLY DETACHED FROM THE DELIVERY WIRE. ALTHOUGH THE 16MM X 14CM RETRACTA COIL DETATCHED UNEXPECTEDLY, IT WAS IN AN ACCEPTABLE POSITION, SO IT WAS LEFT IN THE PATIENT. A SECOND RETRACTA COIL WAS PLACED AND ALSO DETACHED PREMATURELY. THE COIL WAS RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH COOK 0.035 PUSH-ABLE COILS AND 0.018 DETACHABLE COILS FROM ANOTHER MANUFACTURER. THE COMPLAINANT REPORTED NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE. THE FIRST RETRACTA COIL THAT DETACHED PREMATURELY IS CAPTURED UNDER MW# 1820334-2021-00935 (THIS REPORT). THE SECOND RETRACTA COIL THAT DETACHED PREMATURELY AND REQUIRED A SNARE TO RETRIEVE IS CAPTURED UNDER MW# 1820334-2021-00936. REVIEWS OF THE COMPLAINT HISTORY, INTERVIEW OF PERSONNEL, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION WERE CONDUCTED DURING THE INVESTIGATION. ONE USED MWCER DEVICE WAS RETURNED TO COOK FOR EVALUATION. A BLACK CATHETER WAS ALSO RECEIVED. THE CATHETER WAS FLUSHED AND A GUIDE WIRE WAS INSERTED THROUGH THE ENTIRE LENGTH; HOWEVER, NO COILS WERE IN CATHETER. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 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. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: "INSTRUCTIONS FOR USE: NOTE: DO NOT TURN THE DELIVERY WIRE COUNTERCLOCKWISE DURING ADVANCEMENT; THE COIL MAY BE UNINTENTIONALLY DETACHED." "HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THIS EVENT IS COMPONENT FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5, D10. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

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

    Description of Event or Problem · 0

    IN ADDITIONAL INFORMATION RECEIVED ON 18MAR2021, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH COOK 0.035 PUSHABLE COILS AND 0.018 DETACHABLE COILS FROM ANOTHER MANUFACTURER. THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 A MALE PATIENT REQUIRED PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL FOR A GASTRO-DUODENAL ARTERY ANEURYSM EMBOLIZATION PROCEDURE. AFTER ACCESS WAS GAINED VIA SMA ARTERY, THE RETRACTA COIL WAS INSERTED IN A 5FR CATHETER AND THE COIL WAS NOTED TO HAVE UNINTENTIONALLY DETACHED FROM THE DELIVERY WIRE INSIDE THE PATIENT. THE COIL WAS LEFT IN THAT LOCATION. A SECOND RECTRACTA COIL WAS PLACED AND UNINTENTIONALLY DETACHED FROM THE DELIVERY WIRE. THE COIL WAS RETRIEVED WITH A SNARE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THE FIRST RETRACTA COIL THAT DETACHED PREMATURELY IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6) (THIS REPORT). THE SECOND RETRACTA COIL THAT DETACHED PREMATURELY AND REQUIRED A SNARE TO RETRIEVE IS CAPTURED UNDER PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372808 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 9871982 10827002342023

    Patients

    Seq Age Sex Outcome Treatment
    1 Male 6MM X 7CM RETRACTA DETACHABLE COIL| COOK 0.035 PUSHABLE COILS| COOK 5FR 70CM SHEATH| MEDTRONIC 0.018 DETACHABLE COILS| TERUMO 5FR 038 100CM ANGLED TAPER GLIDECATHETER