BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTA DETACHABLE EMBOLIZATION COIL

    MDR report key: 8845300 · Received July 31, 2019

    Report

    Report Number
    1820334-2019-01857
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    June 26, 2019
    Report Date
    October 21, 2019
    Manufacturer
    COOK INC
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT RECEIVED ON: 14AUG2019. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND A VISUAL INSPECTION WERE CONDUCTED DURING THE INVESTIGATION. ONE DAMAGED COIL AND A PORTION OF THE SEPARATED DELIVERY WIRE WERE RETURNED FOR INVESTIGATION. THE CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED. THE COIL WAS RETURNED ELONGATED AND UNRAVELED WITH A PORTION OF THE DELIVERY WIRE COIL PIECE STILL ATTACHED. IT APPEARS TO HAVE SEPARATED NEAR THE SOLDERED JUNCTION. THE OTHER, SEPARATED, PORTION OF THE RETURNED DELIVERY WIRE IS ALSO ELONGATED. DIMENSIONAL MEASUREMENTS COULD NOT BE CONFIRMED BASED ON THE CONDITION OF THE RETURNED DEVICE. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT, THE COIL DELIVERY WIRE SUBASSEMBLY LOT, THE DELIVERY WIRE RAW INCONEL COIL SUBASSEMBLY LOT, AND THE COIL SUBASSEMBLY LOTS REVEALED NO RELATED NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE DEVICE LOT. THERE IS NO EVIDENCE TO SUGGEST THERE IS ANY NONCONFORMING PRODUCT IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT THE FAILURE IS RELATED TO COMPONENT FAILURE WITHOUT A DESIGN OR MANUFACTURING ISSUE. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). SUSPECT MEDICAL DEVICE: PRODUCT INFORMATION CURRENTLY UNAVAILABLE. (B)(6). PMA/510(K) #: K151676. 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 RETRACTA DETACHABLE EMBOLIZATION COIL WAS USED ON AN UNKNOWN PATIENT DURING AN INTERNAL ILIAC ANEURYSM PROCEDURE. DURING THE PROCEDURE, THE OPERATOR WAS NOT SATISFIED WITH THE FIRST PLACEMENT ATTEMPT AND SO THE DEVICE WAS PULLED BACK INTO THE CATHETER. DURING THE SECOND ATTEMPT TO PLACE THE COIL, THE OPERATOR REPORTED PROBLEMS RELEASING THE COIL OUT OF THE CATHETER. THE OPERATOR THEN ATTEMPTED TO PULL THE COIL BACK INTO THE CATHETER AGAIN, BUT REPORTED ¿IT DIDN'T WORK EASILY¿ AND ¿WITH MORE POWER, IT WAS SUCCESSFUL.¿ IT WAS REPORTED A PART OF THE COIL STUCK ON THE TIP OF THE CATHETER. ANOTHER RETRACTA COIL WAS THEN USED 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
    642923 RETRACTA DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD COOK INC N/A 9376078

    Patients

    Seq Age Sex Outcome Treatment
    1 COBRA CATHETER| COBRA CATHETER