BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEFF PERCUTANEOUS ACCESS SET

    MDR report key: 23269885 · Received October 10, 2025

    Report

    Report Number
    1820334-2025-01206
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 21, 2025
    Report Date
    February 24, 2026
    Manufacturer
    COOK INC
    Product Code
    KGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D - PRODUCT IDENTIFIER: THE EXACT DEVICE IS CURRENTLY UNKNOWN. THE BELOW IS BASED ON INFORMATION CURRENTLY AVAILABLE: D1 - BRAND NAME: NEFF PERCUTANEOUS ACCESS SET. D2A - COMMON DEVICE NAME: KGZ ACCESSORIES, CATHETER. D2B - PROCODE: KGZ. E1- POSTAL CODE: (B)(6). H3 - DEVICE EVALUATED BY MFG? DEVICE NOT RETURNED TO MANUFACTURER. H6 - ANNEX F: F28 SELECTED TO CAPTURE THE ABORTED PROCEDURE. 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

    ADDITIONAL INFORMATION: B5 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. CORRECTION: H6 - ANNEX A: INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT A NITINOL WIRE GUIDE FROM AN UNKNOWN NEFF PERCUTANEOUS ACCESS SET SEPARATED DURING A BILIARY ACCESS PROCEDURE. THE PATIENT WAS ALREADY HOSPITALIZED AT THE TIME OF THE INCIDENT. DURING THE PROCEDURE, THE WIRE WAS UNABLE TO BE ADVANCED AND SHEARED IN THE BILIARY DUCT. APPROXIMATELY 1.3CM OF THE DISTAL TIP WAS RETAINED IN THE PATIENT WITH NO PLANS TO REMOVE THE WIRE. THE REMAINING PORTION OF WIRE WAS REMOVED THROUGH THE NEEDLE. THE CUSTOMER REPORTED THAT ANGULATION AND SHEARING CAUSED THE WIRE TO BREAK. THE PROCEDURE WAS ABORTED AS A SUFFICIENT WIRE GUIDE TO PLACE THE NEFF SET IN 2 DUCTS WAS UNAVAILABLE. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS ANATOMY AND "BAD PSC" [PRIMARY SCLEROSING CHOLANGITIS]. NO OTHER ADVERSE EFFECTS WERE REPORTED. REVIEWS OF DOCUMENTATION INCLUDING THE INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES FOR THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. 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 DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH FOR THIS CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT 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 THE FIELD. THIS PRODUCT IS NOT SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET. THE WIRE GUIDE HOLDER IS SUPPLIED WITH AN L_SCOR LABEL ATTACHED INDICATING NOT TO WITHDRAW OR MANIPULATE THE WIRE GUIDE THROUGH A NEEDLE. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDES THIS EVENT TO BE DUE TO USER ERROR AND PATIENT ANATOMY. AS REPORTED, THE PATIENT¿S ANATOMY WAS TORTUOUS. IT IS REASONABLE TO PRESUME THIS LED TO THE REPORTED ANGULATION AND SHEERING OF THE WIRE. IT WAS THEN NOTED THAT REMAINING PORTION OF THE WIRE WAS REMOVED THROUGH THE NEEDLE. LABELING ON THE WIRE GUIDE COMPONENT OF NEFF SETS INDICATES THE WIRE SHOULD NOT BE MANIPULATED OR WITHDRAWN THROUGH THE NEEDLE. 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 A NITINOL WIRE GUIDE FROM AN UNKNOWN NEFF SET SEPARATED DURING A BILIARY ACCESS PROCEDURE. THE PATIENT WAS ALREADY HOSPITALIZED AT THE TIME OF THE INCIDENT. DURING THE PROCEDURE, THE WIRE SHEARED IN THE BILIARY DUCT, AND APPROXIMATELY 1.3CM OF THE DISTAL TIP WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS ABORTED AS A SUFFICIENT WIRE GUIDE TO PLACE THE NEFF SET IN 2 DUCTS WAS UNAVAILABLE. AT THE TIME OF THIS REPORT, NO INTERVENTION OR ADDITIONAL PROCEDURES WERE REQUIRED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 16OCT2025. AS REPORTED, THE SEPARATED PORTION OF THE WIRE WAS RETAINED IN THE PATIENT WITH NO PLANS TO REMOVE THE WIRE. THE REMAINING PORTION OF WIRE WAS REMOVED THROUGH THE NEEDLE. THE CUSTOMER REPORTED THAT ANGULATION AND SHEARING CAUSED THE WIRE TO BREAK. THE PATIENT HAD TORTUOUS ANATOMY AND "BAD PSC" [PRIMARY SCLEROSING CHOLANGITIS]. THE WIRE WAS UNABLE TO BE ADVANCED.

    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
    630522 NEFF PERCUTANEOUS ACCESS SET KGZ ACCESSORIES, CATHETER KGZ COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown