BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 14947619 · Received July 7, 2022

    Report

    Report Number
    1820334-2022-01167
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    April 9, 2021
    Report Date
    December 19, 2022
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002095014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION: UNKNOWN. PMA/510(K) #: EXEMPT. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED BY COOK RESEARCH INC. VIA (B)(6) MEDICAL CENTER (USA) THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER (RPN: ULT8.5-38-25-P-6S-CLM-RH; LOT#: 13804335) MIGRATED NINE DAYS AFTER PLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT A STUDY PROCEDURE (MDR-1919) TO PLACE THE CATHETER FOR ABSCESS DRAINAGE IN THE PERICOLONIC LOWER ABDOMEN. DILATION WAS PERFORMED PRIOR TO CATHETER INSERTION, THEN THE CATHETER WAS PLACED USING COMPUTED TOMOGRAPHY (CT) FOR VISUAL GUIDANCE. ON (B)(6) 2021, A CT IDENTIFIED THAT THE CATHETER HAD RETRACTED OUTSIDE OF THE INTENDED CAVITY. COMPLETE FLUID EVACUATION WAS UNABLE TO BE ACHIEVED WITH THE DEVICE. AS A RESULT, THE PATIENT REQUIRED SURGICAL INTERVENTION TO REPLACE THE DEVICE ON (B)(6) 2021. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS PRIOR TO EXITING THE STUDY. NO OTHER ADVERSE EVENTS WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, MANUFACTURING INSTRUCTIONS AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE INSTRUCTIONS FOR USE (IFU) [ T_MULTI_REV5, MULTIPURPOSE DRAINAGE CATHETER] STATES THE FOLLOWING. "HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. INTENDED USE: MULTIPLE DRAINAGE CATHETERS ARE INTENDED FOR PERCUTANEOUS DRAINAGE APPLICATIONS (E.G NEPHROSTOMY, BILIARY AND ABSCESS), EITHER BY DIRECT STICK OR SELDINGER ACCESS TECHNIQUE. WARNINGS: IF A CATHETER HAS BECOME MALPOSITION OR IF DRAINAGE CEASES, THE CATHETER SHOULD BE PROMPTLY EXCHANGED OR REMOVED. REFERENCES: THESE INSTRUCTIONS FOR USE ARE BASED ON EXPERIENCE FROM PHYSICIANS AND (OR) THEIR PUBLISHED LITERATURE. REFER TO YOUR LOCAL COOK SALES REPRESENTATIVE FOR INFORMATION ON AVAILABLE LITERATURE. ¿ BASED ON THE AVAILABLE INFORMATION, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DISCOVERED TO HAVE MIGRATED OUT OF THE INTENDED CAVITY NINE DAYS AFTER PLACEMENT. THE PATIENT UNDERWENT DRAINAGE CATHETER PLACEMENT ON (B)(6) 2021 FOR ABSCESS DRAINAGE IN THE PERICOLONIC LOWER ABDOMEN. COMPUTED TOMOGRAPHY WAS UTILIZED FOR VISUAL GUIDANCE AND DILATION WAS PERFORMED PRIOR TO CATHETER PLACEMENT. ON (B)(6) 2021, NINE DAYS AFTER PLACEMENT, A CT IDENTIFIED THAT THE CATHETER HAD RETRACTED OUTSIDE OF THE INTENDED CAVITY. COMPLETE FLUID EVACUATION WAS UNABLE TO BE ACHIEVED WITH THE DEVICE. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2021. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS PRIOR TO EXITING THE STUDY.

    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
    2822095 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 13804335 00827002095014

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention