BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 11353379 · Received February 19, 2021

    Report

    Report Number
    1820334-2021-00360
    Event Type
    Injury
    Date Received
    February 19, 2021
    Date of Event
    February 3, 2021
    Report Date
    May 18, 2021
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. (B)(6) IN THE REPUBLIC OF KOREA INFORMED COOK OF AN INCIDENT INVOLVING AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FROM AN UNKNOWN LOT NUMBER. IN THE MORNING OF (B)(6) 2021, A DRAINAGE CATHETER WAS PLACED IN THE PATIENT. IN THE AFTERNOON OF THE SAME DAY, THE CATHETER LEAKED AT THE HUB. THE CATHETER WAS REPLACED WITH A NEW DEVICE THAT WAS COMPLETED WITHOUT ANY COMPLICATIONS. NO OTHER ADVERSE EFFECTS WERE REPORTED. A REVIEW OF THE DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL INSPECTIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. DUE TO THIS, NO DIMENSIONAL, VISUAL, OR FUNCTIONAL VERIFICATIONS COULD BE COMPLETED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE RISK SPECIFICATIONS COVERING MAC-LOC DRAINAGE CATHETERS INCLUDES HUB SEPARATION AS A POTENTIAL FAILURE MODE. THE IDENTIFIED RISK CONTROLS INCLUDE THE MANUFACTURING QUALITY CONTROL CHECKS AND PROCESS VALIDATION. THE TECHNICAL FILES COVERING MAC-LOC DRAINAGE CATHETERS INDICATE THAT THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. BASED ON THE REVIEW OF CURRENT DOCUMENTATION, COOK HAS CONCLUDED THAT INSPECTION ACTIVITIES ARE CURRENTLY IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE IFU SUPPLIED WITH THE MAC-LOC DRAINAGE CATHETERS INSTRUCT THAT THE PRODUCT SHOULD BE INSPECTED PRIOR TO USE TO ENSURE NO DAMAGE HAS OCCURRED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. A GLOBAL SALES SHIPMENT REPORT WAS CONDUCTED FROM (B)(6) 2018 THROUGH (B)(6) 2021 FOR RPN: (B)(4). COOK WAS UNABLE TO NARROW DOWN THE LOT THIS COMPLAINT PERTAINS TO. DUE TO MISSING INFORMATION, THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT FROM THE AFFECTED LOT EXISTS IN HOUSE OR IN THE FIELD. A CAPA WAS PREVIOUSLY OPENED TO INVESTIGATE THIS ISSUE; MANUFACTURING-RELATED ROOT CAUSES WERE IDENTIFIED AND CORRECTIVE ACTIONS WERE IMPLEMENTED. BASED ON THE INFORMATION PROVIDED AND DUE TO THE MANUFACTURED DATE OF THE AFFECTED LOT BEING UNKNOWN, IT IS POSSIBLE A MANUFACTURING OR QUALITY CONTROL DEFICIENCY CONTRIBUTED TO THIS INCIDENT AS DETERMINED FROM THE CAPA INVESTIGATION. 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

    ADDITIONAL PRODUCT CODES: LJE, GBO. PMA/510(K): K173035. (B)(4). 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 AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE. THE DRAINAGE CATHETER WAS PLACED IN THE MORNING. IN THE AFTERNOON, LEAKAGE OCCURRED BETWEEN THE CATHETER AND THE HUB. THE CATHETER WAS REMOVED AND REPLACED SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246897 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention