BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 10734925 · Received October 26, 2020

    Report

    Report Number
    1820334-2020-01943
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    February 19, 2020
    Report Date
    November 17, 2020
    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 METHODS CODE: DEVICE NOT RETURNED (4114). INVESTIGATION ¿ EVALUATION. NANCY VELANDIA FROM BEMEL LOGISTICS/ADVANCED INFORMED COOK OF AN INCIDENT IN COLUMBIA INVOLVING AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. ON (B)(6) 2020 DURING A PROCEDURE THE METAL STIFFENER COULD NOT BE REMOVED FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. 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, QUALITY CONTROL, AND SPECIFICATIONS OF THE 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. THE RISK SPECIFICATIONS COVERING MAC-LOC DRAINAGE CATHETERS INCLUDE DIFFICULT INSERTING/REMOVING THE METAL STIFFENER INTO THE CATHETER AND DAMAGE TO THE CATHETER DURING INTRODUCTION OF THE METAL STIFFENING CANNULA. THE IDENTIFIED RISK CONTROL INCLUDES 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. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE IFU SUPPLIED WITH MAC-LOC DRAINAGE CATHETERS INSTRUCT THAT THE PRODUCT SHOULD BE INSPECTED PRIOR TO USE TO ENSURE NO DAMAGE HAS OCCURRED. 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 WERE REVIEWED AND ONE RELEVANT NONCONFORMANCE FOR ¿TRANSITION, POOR" WAS NOTED. THIS AFFECTED A QUANTITY OF 16 THAT ALL HAD A DISPOSITION SCRAPPED. A DATABASE SEARCH WAS COMPLETED ON THE LOT AND NO ADDITIONAL COMPLAINTS WERE FOUND. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, NONCONFORMING DEVICES WERE SCRAPPED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED 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 IS CURRENTLY OPEN TO ADDRESS METAL STIFFENER ADVANCEMENT AND REMOVAL DIFFICULTY. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. 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 COMMON DEVICE NAMES: LJE CATHETER, NEPHROSTOMY ; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY. OCCUPATION: UNKNOWN. 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

    IT WAS REPORTED A FEMALE PATIENT REQUIRED AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR A BILIARY BYPASS PROCEDURE. AT THE TIME OF INSERTING THE CATHETER AND METAL STIFFENER COMBINATION AND ATTEMPTING TO REMOVE THE METAL STIFFENER, IT WAS NOT POSSIBLE TO REMOVE IT. REMOVAL WAS ATTEMPTED MULTIPLE TIMES WITH NO SUCCESS. THE CATHETER WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE 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
    1199077 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 9971679 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR