BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 10130380 · Received June 8, 2020

    Report

    Report Number
    1820334-2020-01089
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 30, 2020
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002094970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6 ¿ METHOD CODE: (4114) DEVICE NOT RETURNED. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE METAL STIFFENER WITHIN A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER COULD NOT BE REMOVED FROM THE CATHETER. THIS INCIDENT WAS REPORTED BY (B)(6) HOSPITAL, (B)(6) , IN THE REPUBLIC OF KOREA. NO ADVERSE EFFECTS WERE REPORTED. 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 COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. THEREFORE, NO VISUAL INSPECTION WAS PERFORMED. ADDITIONALLY, 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 INSTRUCTIONS FOR USE (IFU) WERE REVIEWED FOR THIS FAILURE MODE. 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. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS RECORDS ONE RELEVANT NON-CONFORMANCE FOR ¿I.D. INCORRECT." HOWEVER, ALL NONCONFORMING PRODUCT WAS SCRAPPED, THERE IS A 100% INSPECTION FOR THE REPORTED NONCONFORMANCE, AND NO ADDITIONAL COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD FOR THIS LOT. DUE TO THIS INFORMATION, COOK COULD NOT CONCLUDE THAT NONCONFORMING PRODUCTS FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE/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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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

    ADDITIONAL INFORMATION RECEIVED 10JUN2020: IT WAS CONFIRMED THAT THE METAL STIFFENER WAS THE STIFFENER THAT EXPERIENCED DIFFICULTY IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: LJE; GBO. 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

    AS REPORTED, AN UNKNOWN PATIENT REQUIRED PLACEMENT OF A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR AN ABDOMINAL ABSCESS DRAINAGE PROCEDURE. THE OPERATOR REPORTED, "CATHETER AND CANNULA WAS NOT SEPARATED, MAYBE IT WAS JAMMED AT THE CATHETER TIP." 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
    593862 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 10258949 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO WIRE GUIDE