BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGE CATHETER, BILIARY, DIAGNOSTIC

    MDR report key: 18314500 · Received December 12, 2023

    Report

    Report Number
    1820334-2023-01688
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Report Date
    March 25, 2024
    Manufacturer
    COOK INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION / EVALUATION: IT WAS REPORTED THAT AN UNKNOWN 16 FRENCH BILIARY DRAIN LEAKED. THE PATIENT HAS THE DRAIN ROUTINELY REPLACED. THERE IS NO INDICATION THAT THE PATIENT REQUIRED AN ADDITIONAL, UNSCHEDULED PROCEDURE DUE TO THIS OCCURRENCE. NO PATIENT HARM HAS BEEN REPORTED. INFORMATION PROVIDED INDICATED THAT THE COMPLAINT DEVICE IS LIKELY A ULT16.0-38-40-P-32S-BCL-HC, COOK-COPE TYPE LOOP BILIARY DRAINAGE CATHETER. REVIEWS OF DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES FOR THE SUSPECT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE A COMPLETE RPN OR A LOT NUMBER. HOWEVER, AN EXPANDED SALES SEARCH FOR THE SUSPECT COOK-COPE TYPE LOOP BILIARY DRAINAGE CATHETER PRODUCT LINE SHIPPED TO THIS CUSTOMER DURING A 3 YEAR PERIOD WAS PERFORMED. COOK MEDICAL REVIEWED SALES RECORDS AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. AS A RESULT, COOK MEDICAL INC. WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT T_MULTI2_REV1 IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: "PRECAUTIONS CATHETERS SHOULD BE IRRIGATED ON A ROUTINE BASIS TO ENSURE FUNCTION. PATIENTS WITH INDWELLING DRAINAGE CATHETERS SHOULD BE EVALUATED ROUTINELY TO ENSURE CONTINUOUS FUNCTION OF THE CATHETER." ¿HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK MEDICAL HAS CONCLUDED THE ROOT CAUSE CATEGORY WOULD FALL UNDER CAUSE TRACED TO COMPONENT FAILURE, BEING DEFINED AS COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D1 - PRODUCT IDENTIFIER/BRAND NAME: THE EXACT DEVICE IS CURRENTLY UNKNOWN. A POSSIBLE MODEL NUMBER WAS PROVIDED: ULT16.0-38-40-P-32S-BCL-HC D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY, LJE CATHETER, NEPHROSTOMY D2B - PROCODE: ADDITIONAL PRODUCT CODES: GBO, LJE E1 - CUSTOMER (PERSON): ADDRESS: (B)(6). 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

    IT WAS REPORTED THAT AN UNKNOWN 16 FRENCH BILIARY DRAIN LEAKED. THE PATIENT HAS THE DRAIN ROUTINELY REPLACED. 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
    1525672 FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown