BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET

    MDR report key: 12509090 · Received September 21, 2021

    Report

    Report Number
    1820334-2021-02190
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    September 15, 2021
    Report Date
    January 12, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    10827002069296
    PMA / PMN Number
    K171820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. KLINIKUM DORTMUND GGMBH IN GERMANY REPORTED AN ISSUE WITH A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET (RUPS-100) FROM LOT 13880996. RUST WAS NOTED ON THE SURFACE OF TWO TROCAR STYLETS, ONE PRIOR TO PATIENT CONTACT AND THE OTHER USED DURING A PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES AND SPECIFICATIONS, AS WELL AS VISUAL INSPECTION OF THE RETURNED PRODUCT, WAS CONDUCTED DURING THE INVESTIGATION. ONE, PRIOR TO USE STYLET-CATHETER SUBASSEMBLY WAS RETURNED OPENED. UPON VISUAL EXAMINATION, A RUST-COLORED LIKE SUBSTANCE WAS FOUND ON THE ENTIRE SURFACE OF THE STYLET. THE DEVICE WAS SENT TO COOK RESEARCH, INC (CRI) FOR FURTHER ANALYSIS. SCANNING ELECTRON MICROSCOPY (SEM) AND ENERGY-DISPERSIVE SPECTROSCOPY (EDS) WERE PERFORMED ON THE RETURNED SAMPLE, IN WHICH ZINC (ZN), CHLORINE (CL) AND TIN (SN) WERE DETECTED ON THE SURFACE OF THE DISCOLORED AREA. THESE ELEMENTS COULD POSSIBLY BE REMNANTS OF THE SOLDER/FLUX. IT IS FEASIBLE TO SUGGEST THAT THESE REMNANTS POTENTIALLY CAUSED THE OBSERVED CORROSION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 13880996 AND RELATED SUBASSEMBLIES FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. AN EXPANDED LOT SEARCH WAS PERFORMED. FINAL LOTS CONTAINING THE SAME CANNULA SUBASSEMBLY LOTS WERE REVIEWED. FOURTEEN (14) OTHER LOTS WERE FOUND. NO OTHER COMPLAINTS WERE NOTED FOR THIS SAME FAILURE MODE. ADDITIONALLY, RETURNED RUPS DEVICES FROM OTHER PREVIOUS COMPLAINTS AND INVENTORY AT A DISTRIBUTION CENTER WERE EXAMINED FOR TRACES OF RUST, AND NO EVIDENCE OF RUST WAS FOUND ON ANY OF THESE DEVICES. THE INFORMATION PROVIDED UPON REVIEW OF THE RETURNED DEVICE SUGGESTS THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, REVIEW OF THE DMR, AND DHR SUGGESTS THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT T_RUPS_REV4 [ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET] IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A MANUFACTURING DEFICIENTLY CONTRIBUTED TO THE REPORTED EVENT. IT IS POSSIBLE THAT SOLDER AND/OR FLUX REMAINED ON THE DEVICE, CAUSING CORROSION AND THE OBSERVED DISCOLORATION. 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 PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    CUSTOMER (PERSON): PHONE: (B)(6). OCCUPATION: LEADING RADIOGRAPHER. 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 THAT RUST WAS DISCOVERED ON THE TROCAR STYLETS INCLUDED IN TWO ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SETS. DURING PREPARATION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPPS) PROCEDURE, IT WAS NOTED THAT THE TROCAR STYLET APPEARED TO BE RUSTED. FRICTION WAS PALPABLE BY HAND ON THE RUSTED PORTION AND IT WAS DECIDED THAT THE TROCAR WOULD NOT BE USED IN THE PROCEDURE. ANOTHER ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET FROM THE SAME LOT WAS THEN OPENED, HOWEVER, THE SAME COLOR CHANGE WAS NOTED TO THE STYLET IN THAT SET. AS THERE WAS NO FRICTION PALPABLE ON THE SECOND TROCAR, IT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1404064 ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 13880996 10827002069296

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown