BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 19176105 · Received April 24, 2024

    Report

    Report Number
    1820334-2024-00575
    Event Type
    Injury
    Date Received
    April 24, 2024
    Report Date
    August 22, 2024
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2A- ADDITIONAL COMMON NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY D2B- ADDITIONAL PRODUCT CODES: GBO; LJE G4- PMA/510(K) #: K173035 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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    CORRECTION: B2, D4-MODEL#, H6-ANNEX G. INVESTIGATION ¿ EVALUATION. ON (B)(6) 2024, IT WAS REPORTED THAT (B)(4) UNKNOWN PATIENTS ON UNKNOWN DATES REQUIRED REPLACEMENT OF ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS. IT WAS SAID THAT THE WHITE MAC LOC PORTION OF THE CATHETER SEPARATED FROM THE CATHETER WHEN THE CATHETERS WERE PULLED. THE SEPARATION OCCURRED AFTER THE PATIENTS HAD LEFT THE PROCEDURE ROOM OR HAD GONE HOME. THE PATIENTS HAD TO BE BROUGHT BACK TO THE PROCEDURE ROOM FOR REPLACEMENT OF THE DEVICES. IT IS UNKNOWN HOW LONG THE DEVICES WERE IN PLACE OR THE ACTIVITY LEVEL OF THE PATIENTS. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF THE DOCUMENTATION, INCLUDING THE QUALITY CONTROL PROCEDURES, INSTRUCTIONS FOR USE AND SPECIFICATIONS OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE DHR WAS UNABLE TO BE COMPLETED, DUE TO THE LACK OF LOT INFORMATION FROM THE COMPLAINT FACILITY. COOK ALSO REVIEWED PRODUCT LABELING: THE INSTRUCTIONS FOR USE (IFU) [ T_MULTI2 REV1, MULTIPURPOSE DRAINAGE CATHETER] STATES THE FOLLOWING. HOW SUPPLIED: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE REVIEW OF CURRENT DOCUMENTATION, COOK HAS CONCLUDED THAT INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. REVIEW OF PRODUCT LABELING: COOK REVIEWED THE PRODUCT LABELING FOR THE COMPLAINT DEVICE. THE INSTRUCTIONS FOR USE (IFU) [ T_MULTI2_REV1, MULTIPURPOSE DRAINAGE CATHETER] STATES THE FOLLOWING. PRECAUTIONS: PATIENTS WITH INDWELLING DRAINAGE CATHETERS SHOULD BE EVALUATED ROUTINELY TO ENSURE CONTINUOUS FUNCTION OF THE CATHETER. EVIDENCE GATHERED 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 PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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

    IT WAS REPORTED THAT 4 UNKNOWN PATIENTS ON UNKNOWN DATES REQUIRED REPLACEMENT OF ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS. IT WAS SAID THAT THE WHITE MAC LOC PORTION OF THE CATHETER SEPARATED FROM THE CATHETER WHEN THE CATHETERS WERE PULLED. THE SEPARATION OCCURRED AFTER THE PATIENTS HAD LEFT THE PROCEDURE ROOM OR HAD GONE HOME. THE PATIENTS HAD TO BE BROUGHT BACK TO THE PROCEDURE ROOM FOR REPLACEMENT OF THE DEVICES. IT IS UNKNOWN HOW LONG THE DEVICES WERE IN PLACE OR THE ACTIVITY LEVEL OF THE PATIENTS. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156056 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC G09501 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention