BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 24256232 · Received February 4, 2026

    Report

    Report Number
    3002808486-2026-00020
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 5, 2026
    Report Date
    March 26, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4: SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K220137. INVESTIGATION IS STILL IN PROGRESS. 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

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE ZTA-PT-42-38-173-W1 WAS DELIVERED, AND AFTER DEPLOYMENT, ONLY THE DILATOR WAS REMOVED. WHEN FLUSHING THE DILATOR'S WIRE LUMEN, BLACK FOREIGN MATTER EMERGED FROM THE TIP. PREOPERATIVE PREPARATION WAS PERFORMED ACCORDING TO THE PACKAGE INSERT. SUSPECTED TO BE METAL FRAGMENTS FROM THE LUNDERQUIST WIRE GUIDE. ALL SUSPECTED ITEMS INCL. BLACK FOREIGN MATTER/FRAGMENTS WERE RETRIEVED AND THE PATIENT RECOVERED. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. THE COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. THE WIRE GUIDE AND PHOTOGRAPHIC EVIDENCE WERE RETURNED FOR EVALUATION. THE DEVICE EVALUATION AND THE REVIEW OF THE PHOTO DETERMINED THE FOLLOWING: THE PHOTO SHOWED AN UNIDENTIFIED FRAGMENT IN A SMALL PLASTIC BIN. THE PLASTIC BIN WITH FRAGMENTS, THE ZTA DEVICE, AND THE LES WIRES GUIDE WERE RETURNED. ON THE WIRE GUIDE SOME SCRATCHES WERE NOTED IN THE COATING AND WHEN FLUSHING THE ZTA ANOTHER FRAGMENT BECAME VISIBLE. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE HAS NOT PREVIOUSLY OCCURRED FOR THIS MANUFACTURING LOT. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. COOK CONDUCTED A REVIEW OF THE PACKAGING LABEL (WHOLE DEVICE), WHICH REVEALED NO DISCREPANCIES. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSES MAY INCLUDE DAMAGED WIRE GUIDE COATING. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AS THE COMPLAINT FALLS WITHIN THE SCOPE OF AN ONGOING INTERNAL ACTION. A CAPA HAS BEEN INITIATED TO ADDRESS THE WIRE GUIDE COATING PROCESS AND IS STILL ONGOING. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2022: 81-YEAR-OLD MALE PATIENT UNDERWENT TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR). TEVAR WAS PERFORMED ON A DESCENDING THORACIC ANEURYSM (NEAR TH6-TH9) USING ZTA-P-34-113-W1 (E4197187) AND ZTA-DE-34-112-W1 (E4259250). IN THIS CASE, THE PROCEDURE WAS EXTENDED WITH A 112MM EXTENSION, WITH THE UNDERSTANDING THAT 113MM WAS INSUFFICIENT, IN ORDER TO SHORTEN THE TREATMENT LENGTH. (B)(6) 2026: DURING ENDOLEAK RESPONSE, THE ZTA-PT-42-38-173-W1 WAS DELIVERED, AND AFTER DEPLOYMENT, ONLY THE DILATOR WAS REMOVED. WHEN THE NURSE FLUSHED THE DILATOR'S WIRE LUMEN, BLACK FOREIGN MATTER EMERGED FROM THE TIP. PREOPERATIVE PREPARATION WAS PERFORMED ACCORDING TO THE PACKAGE INSERT. SUSPECTED TO BE METAL FRAGMENTS FROM THE LUNDERQUIST (TSCMG-35-300-LESDC/E4737302). ALL SUSPECTED ITEMS WERE RETRIEVED. (ZTA-PT-42-38-173-W1 SHEATH AND DILATOR, LUNDERQUIST, AND BLACK FOREIGN MATTER). PATIENT OUTCOME: THE PATIENT WAS RECOVERED.

    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
    342300 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E4737302 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male