BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET

    MDR report key: 17191641 · Received June 23, 2023

    Report

    Report Number
    1820334-2023-00807
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    January 12, 2023
    Report Date
    July 13, 2023
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002297692
    PMA / PMN Number
    K171820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION ON (B)(6)2023, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM A PHYSICIAN OF THE UNIVERSITY HEALTH SYSTEMS, LOCATED IN SAN ANTONIO, TEXAS (USA). IT WAS REPORTED THAT THE DILATOR WAS UNABLE TO BE INSERTED INTO THE SUPPLIED SHEATH FROM A RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET (RPN: RTPS-100-10.0; LOT#: 14808919). THE SHEATH WAS FLUSHED DURING PREPARATION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE DILATOR WAS UNABLE TO BE INSERTED INTO THE SHEATH, SO THE FLUSH OF THE SHEATH WAS REPEATED. THEY WERE STILL UNABLE TO INSERT THE DILATOR. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW SEPARATE SHEATH WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE SUPPLIED KCFW-10.0-35-RB-RTPS-100, SHEATH, AND JCD11.0-38-20, DILATOR, FROM THE RTPS-100-10.0, RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET WERE RETURNED IN AN OPENED AND PREPPED CONDITION. DURING THE INITIAL INVESTIGATION, THE DILATOR WAS CONFIRMED TO ONLY ADVANCE INTO THE CHECK-FLO AND SHEATH AT APPROXIMATELY 5.0 CM. DURING TABLE TOP TESTING, THE CHECK-FLO BODY WAS REMOVED FROM THE SHEATH AND UNRAVELLING OF THE COIL WAS DISCOVERED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. COOK ALSO COMPLETED A REVIEW OF OF THE DHR FOR LOT 14808919 CONFIRMING THERE WERE NO RELEVANT RECORDED NONCONFORMANCES OR ADDITIONAL COMPLAINTS RECEIVED. THE SUBASSEMBLY LOTS WERE REVIEWED AND A TOTAL OF 3 RELEVANT NONCONFORMANCES WERE RECORDED. THESE NONCONFORMANCES WERE SCRAPPED PRIOR TO FURTHER PROCESSING OF THE ORDER. AN EXPANDED SEARCH FOR THE APPLIED RAW LOTS, REGARDING THE REINFORCED TUBING WAS PERFORMED, IDENTIFYING 29 LOTS. A REVIEW OF THESE LOTS DISCOVERED ONE ADDITIONAL COMPLAINT RECEIVED. THE INVESTIGATIONAL FINDINGS CONFIRMED THIS COMPLAINT NOT TO BE RELEVANT TO THE REPORTED DIFFICULTY. SINCE THERE IS OBJECTIVE EVIDENCE THE DHR WAS FULLY EXECUTED, AND THERE ARE NO OTHER LOT-RELATED COMPLAINTS BEING RECEIVED FOR ADVANCEMENT DIFFICULTIES OF DILATOR THROUGH SHEATH, COOK MEDICAL INC. HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT ADDITIONAL NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_RTPS_REV5] "RING TRANSJUGULAR INTRAHEPATIC ACCESS SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: "BEFORE INTRODUCTION AND PERIODICALLY DURING THE PROCEDURE, THE TRANSJUGULAR INTRODUCER SHEATH SHOULD BE FLUSHED WITH SALINE." THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, IFU AND DHR SUGGESTS THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, THERE IS NO EVIDENCE THAT ADDITIONAL PRODUCT WAS AFFECTED OR THAT NON-CONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK MEDICAL HAS CONCLUDED THE ROOT CAUSE WAS A MANUFACTURING RELATED DEFICIENCY. 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.

    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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR IS IT ADMISSION 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

    IT WAS REPORTED, THAT THE DILATOR WAS UNABLE TO BE INSERTED INTO THE SHEATH. FROM A RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET. THE SHEATH WAS FLUSHED DURING PREPARATION FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE DILATOR WAS UNABLE TO BE INSERTED INTO THE SHEATH, SO THE FLUSH OF THE SHEATH WAS REPEATED. THEY WERE STILL UNABLE TO INSERT THE DILATOR. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW SEPARATE SHEATH WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES, DUE TO THIS OCCURRENCE. UPON ANALYSIS OF THE RETURNED DEVICE, IT WAS CONFIRMED, THAT THE DILATOR WOULD ONLY ADVANCE INTO THE SHEATH APPROXIMATELY 5 CM. UPON FURTHER TESTING OF THE DEVICE, DAMAGE TO THE INNER LINER OF THE SHEATH AND UNRAVELING OF THE COIL NEAR THE FLARE WERE FOUND, THUS PROMPTING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757924 RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 14808919 00827002297692

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown