BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 10919176 · Received November 30, 2020

    Report

    Report Number
    1820334-2020-02189
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    October 15, 2020
    Report Date
    January 8, 2021
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002094970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. ADDITIONAL METHOD CODE: DEVICE NOT RETURNED (4114). INVESTIGATION ¿ EVALUATION. AGILITY LOGISTICS INFORMED COOK OF AN INCIDENT THAT OCCURRED IN BRAZIL INVOLVING AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. ON 15OCT2020 DURING AN EXTERNAL BILE DRAINAGE PROCEDURE, THE METAL STIFFENER COULD NOT BE REMOVED FROM THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION OF THE PHOTOS PROVIDED BY THE CUSTOMER, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. HOWEVER, THE CUSTOMER PROVIDED IMAGES OF THE DEVICE THAT FAILED. IN THE IMAGES, THERE IS BIOMATTER PRESENT ON THE DEVICE. THERE IS A PICTURE OF A CATHETER WITH A METAL STIFFENER INSERTED INSIDE. THE METAL STIFFENER IS NOT FULLY INSERTED WITHIN THE CATHETER. IT APPEARS TO BE PULLED OUT BY A FEW CENTIMETERS. THE CATHETER¿S SHAFT HAS SOME BUNCHES IN THE MATERIAL. THERE APPEARS TO BE NO DAMAGE TO THE DEVICE. 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 IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION TO CHECK FOR FAILURE RELATED NONCONFORMANCES AND ADDITIONAL COMPLAINTS. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS RECORDED NON-CONFORMANCES. COOK CONCLUDED THE RECORDED NON-CONFORMANCES ARE NOT RELATED TO THIS INCIDENT. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE DEVICE LOT. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES AND NO ADDITIONAL COMPLAINTS FROM THE SAME LOT, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A CAPA WAS PREVIOUSLY OPEN TO ADDRESS METAL STIFFENER ADVANCEMENT AND REMOVAL DIFFICULTY. THE CAPA CONCLUDED WITH MANUFACTURING AND DESIGN VALIDATION DEFICIENCIES. THE COMPLAINT LOT WAS MANUFACTURED PRIOR TO CAPA IMPLEMENTATION ACTIVITIES. BASED ON THE INFORMATION PROVIDED, MANUFACTURE DATE OF THE LOT NUMBER, AND THE RESULTS OF THE INVESTIGATION, THE INVESTIGATION WILL CONCLUDE WITH A MANUFACTURING AND A DEVICE DESIGN DEFICIENCY. 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. OCCUPATION: PHARMACEUTICAL. 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.

    Description of Event or Problem · 1

    AS REPORTED, AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER DURING A PERCUTANEOUS BILIARY CATHETERIZATION PROCEDURE. THE OPERATOR REPORTED THAT UPON ATTEMPTING TO REMOVE THE METAL STIFFENER FROM THE CATHETER, IT WOULD NOT COME OUT. THEREFORE, THE CATHETER WAS REMOVED FROM THE PATIENT. ANOTHER SIMILAR DEVICE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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
    1382750 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 10139012 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1