BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 22306777 · Received June 23, 2025

    Report

    Report Number
    3002808486-2025-00138
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    June 8, 2025
    Report Date
    October 3, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    10827002314532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). 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). AFTER INVESTIGATION THE EVENT IS NO LONGER CONSIDERED REPORTABLE AS IT IS ASSESSED TO BE A SIDE EFFECT AND NOT DUE TO THE DEVICE. SUMMARY OF INVESTIGATIONAL FINDINGS: DURING THE PROCEDURE, A MERIT 'S 6F ARTERIAL SHEATH WAS PLACED, AND A COMMON LOACH GUIDEWIRE WAS ENTERED ALONG THE ARTERIAL SHEATH UP TO THE ASCENDING AORTA, AND THEN REPLACED WITH CATHETER (N5.0-35-100-P-10S-PIG-CSC-20), CONTRAST, AND REPLACED WITH A WIRE GUIDE (TSMG-35-260-LES) TO THE AORTIC SINUS, AND THE PROXIMAL END OF THE WIRE GUIDE APPEARED TO BE BENT, AND IMMEDIATELY WITHDRAW THE TSMG-35-260-LES GUIDEWIRE WITH THE N5.0-35-100-P-10S-PIG-CSC-20 CATHETER, REPLACE IT WITH A NEW TSMG-35-260-LES, AND THEN PROCEED WITH COMPRESSION DEVICE IMPLANTATION, RELEASE OF THE VALVE, REPLACEMENT OF THE N5.0-35-100-P-10S-PIG-CSC-20, AND IMAGING TO CONFIRM THAT THE PROCEDURE WENT WELL AND THAT THE PATIENT CONDITION IMPROVED AND ENDED THE SURGERY. THE TSMG-35-260-LES WITHOUT MALE LUER CAP AND WIRE STRAIGHTENER WAS RETURNED FOR EVALUATION. DEVICE EVALUATION CONFIRMED THAT THE WIRE GUIDE, SOLD AS STRAIGHT, WAS CURVED AND BENT UPON RECEIPT. BASED ON THE PROVIDED INFORMATION AND THE DEVICE EVALUATION, AN EXACT CAUSE FOR THE BENT COULD NOT BE DETERMINED. IF ATTEMPTS HAVE BEEN MADE TO ALTER THE TIP DURING PREPARATION, BENDING IT WITH A TOOL, WHILE TRYING TO HOLD THE WIRE GUIDE, COULD HAVE CONTRIBUTED TO THE DAMAGE. ACCORDING TO THE INSTRUCTIONS FOR USE, ALTERING THE TIP CONFIGURATION OF THE WIRE GUIDE MAY RESULT IN DAMAGE. OTHERWISE, THE WIRE GUIDE MAY HAVE BENT DUE TO MULTIPLE DEVICE REPLACEMENTS DURING THE PROCEDURE. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL DISCOVERED NON-CONFORMANCES WERE PROPERLY SCRAPPED AND REPLACED BEFORE RELEASE AND NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATION. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCTS EXIST IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE PROCEDURE, A MERIT 'S 6F ARTERIAL SHEATH WAS PLACED, AND A COMMON LOACH GUIDEWIRE WAS ENTERED ALONG THE ARTERIAL SHEATH UP TO THE ASCENDING AORTA, AND THEN REPLACED WITH CATHETER (N5.0-35-100-P-10S-PIG-CSC-20), CONTRAST, AND REPLACED WITH A WIRE GUIDE (TSMG-35-260-LES )TO THE AORTIC SINUS, AND THE PROXIMAL END OF THE WIRE GUIDE APPEARED TO BE BENT, AND IMMEDIATELY WITHDRAW THE TSMG-35-260-LES GUIDEWIRE WITH THE N5.0-35-100-P-10S-PIG-CSC-20 CATHETER, REPLACE IT WITH A NEW TSMG-35-260-LES, AND THEN PROCEED WITH COMPRESSION DEVICE IMPLANTATION, RELEASE OF THE VALVE, REPLACEMENT OF THE N5.0-35-100-P-10S-PIG-CSC-20, AND IMAGING TO CONFIRM THAT THE PROCEDURE WENT WELL AND THAT THE PATIENT CONDITION IMPROVED AND ENDED THE SURGERY. PATIENT OUTCOME. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837925 LUNDERQUIST EXTRA-STIFF STRAIGHT EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G31453 E4672824 10827002314532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown