BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE BILIARY DRAINAGE CATHETER

    MDR report key: 11408181 · Received March 3, 2021

    Report

    Report Number
    1820334-2021-00874
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    February 17, 2021
    Report Date
    February 1, 2022
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002289499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: AS REPORTED, ON (B)(6) 2021, AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE BILIARY DRAINAGE CATHETER (RPN: ULT8.5-38-40-P-6S-HIRATA-110184, PRODUCT LOT NUMBER: 13525499) IN THE BILE DUCT DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM DRAINAGE PROCEDURE. THE ACCESS WAS GAINED VIA SELDINGER TECHNIQUE. ON (B)(6) 2021, THE PATIENT REPORTED THAT HE ¿MOVED¿ HIS/HER BODY AND THE CATHETER SEPARATED FROM HUB. LEAKAGE WAS OBSERVED. AS A TEMPORARY REPAIR, THE CATHETER WAS CONNECTED TO A DRAINAGE BAG. THE FOLLOWING DAY, THE DEVICE WAS REMOVED, AND A SIMILAR DEVICE WAS PLACED TO CONTINUE TREATMENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL AND SPECIFICATIONS OF THE PRODUCT WAS 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 CURRENTLY IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE RISK SPECIFICATIONS COVERING MAC-LOC DRAINAGE CATHETERS INCLUDES HUB SEPARATION AS A POTENTIAL FAILURE MODE. THE IDENTIFIED RISK CONTROLS INCLUDE 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT: 13525499 FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. THERE IS NO INDICATION THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION, AND NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THE IFU SUPPLIED WITH THE MAC-LOC DRAINAGE CATHETERS INSTRUCT THAT THE PRODUCT SHOULD BE INSPECTED PRIOR TO USE TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE ROOT CAUSE OF THE FAILURE COULD BE ATTRIBUTED TO A COMPONENT FAILURE WITHOUT DESIGN OR MANUFACTURING DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. RPN: ULT8.5-38-40-P-6S-HIRATA-110184. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE BILIARY DRAINAGE CATHETER (VIA SELDINGER TECHNIQUE) IN THE BILE DUCT FOR A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAM DRAINAGE PROCEDURE. ONE DAY AFTER PLACEMENT, THE PATIENT MOVED HIS/HER BODY AND THE CATHETER SEPARATED FROM THE HUB. LEAKAGE WAS OBSERVED. AS A TEMPORARY REPAIR, THE CATHETER WAS CONNECTED TO A DRAINAGE BAG. THE FOLLOWING DAY, THE DEVICE WAS REMOVED AND ANOTHER SIMILAR DEVICE WAS PLACED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302711 ULTRATHANE BILIARY DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 13525499 00827002289499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention