BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 22371719 · Received July 1, 2025

    Report

    Report Number
    1820334-2025-00801
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    July 30, 2024
    Report Date
    September 23, 2025
    Manufacturer
    COOK INC
    Product Code
    DQX
    PMA / PMN Number
    K171764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D1: UNSPECIFIED COOK ROSEN WIRE GUIDE D4: POSSIBLE MODEL AND RPNS: G01774, THSCF-35-80-1.5-ROSEN. G01261, THSCF-35-145-1.5-ROSEN. G01264, THSCF-35-180-1.5-ROSEN. G01623, THSCF-35-220-1.5-ROSEN. G01253, THSCF-35-260-1.5-ROSEN. 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, 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

    SUMMARY OF EVENT: AS REPORTED, FIVE DAYS AFTER AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR AN AORTIC DEGENERATIVE ANEURYSM, DURING WHICH AN UNSPECIFIED COOK ROSEN WIRE GUIDE WAS USED, AN INFRARENAL ARTERIO-VENOUS (AV) FISTULA WAS NOTED. PERCUTANEOUS ACCESS WAS OBTAINED IN THE RIGHT AND LEFT FEMORAL ARTERIES FOR THE EVAR PROCEDURE. SIDE-BRANCH CATHETERIZATION AND PLACEMENT OF BRIDGING STENTS WAS SUCCESSFUL, AND ALL TARGET VESSELS WERE PATENT. TWO STENTS (OTHER MANUFACTURER) WERE PLACED IN THE LEFT RENAL ARTERY DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE EVAR PROCEDURE, AND NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE EVAR. PER THE REPORTER, FORMATION OF THE AV FISTULA WAS PROBABLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO BOTH ANOTHER MANUFACTURER¿S WIRE AS WELL AS THE COMPLAINT DEVICE, AS BOTH WIRES WERE ¿APPLIED¿ DURING CANNULATION OF THE LEFT RENAL ARTERY. PER THE REPORTER, THE ¿MOST PROBABLE CAUSE FOR THE ACUTE AV FORMATION IS A TRAUMA TO THE ARTERIAL WALL CAUSED BY A GUIDEWIRE¿; HOWEVER, IT IS UNKNOWN IF THE TRAUMA WAS CAUSED BY THE COOK WIRE. PER THE REPORTER, THE EVENT DID NOT OCCUR DUE TO A DEVICE DEFICIENCY. THE USER STATED THAT THE DISEASE DID NOT CAUSE THE EVENT, NOR DID ANY OTHER CONDITION OR CIRCUMSTANCE. THE FISTULA WAS TREATED WITH AN ENDOVASCULAR COIL EMBOLIZATION. THE PATIENT RECOVERED WITHOUT SEQUELAE, AND THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED TO HOME FOURTEEN DAYS AFTER THE EVAR PROCEDURE. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. THE RPN AND LOT NUMBER WERE NOT PROVIDED TO COOK; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES ¿DO NOT ADVANCE OR WITHDRAW A WIRE GUIDE WHEN RESISTANCE IS ENCOUNTERED, AS A PERFORATION COULD OCCUR.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO MITIGATE THIS EVENT PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT PROCEDURAL ISSUES LIKELY CONTRIBUTED TO THIS EVENT. THE RISK ANALYSIS WAS REVIEWED, AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    AS REPORTED, FIVE DAYS AFTER AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR AN AORTIC DEGENERATIVE ANEURYSM, DURING WHICH AN UNSPECIFIED COOK ROSEN WIRE GUIDE WAS USED, AN INFRARENAL ARTERIO-VENOUS (AV) FISTULA WAS NOTED. PERCUTANEOUS ACCESS WAS OBTAINED IN THE RIGHT AND LEFT FEMORAL ARTERIES FOR THE EVAR PROCEDURE. SIDE-BRANCH CATHETERIZATION AND PLACEMENT OF BRIDGING STENTS WAS SUCCESSFUL, AND ALL TARGET VESSELS WERE PATENT. TWO STENTS (OTHER MANUFACTURER) WERE PLACED IN THE LEFT RENAL ARTERY DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE EVAR PROCEDURE, AND NO ADDITIONAL PROCEDURES WERE PERFORMED DURING THE EVAR. PER THE REPORTER, FORMATION OF THE AV FISTULA WAS PROBABLY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO BOTH ANOTHER MANUFACTURER¿S WIRE AS WELL AS THE COMPLAINT DEVICE, AS BOTH WIRES WERE "APPLIED" DURING CANNULATION OF THE LEFT RENAL ARTERY. PER THE REPORTER, THE "MOST PROBABLE CAUSE FOR THE ACUTE AV FORMATION IS A TRAUMA TO THE ARTERIAL WALL CAUSED BY A GUIDEWIRE"; HOWEVER, IT IS UNKNOWN IF THE TRAUMA WAS CAUSED BY THE COOK WIRE. PER THE REPORTER, THE EVENT DID NOT OCCUR DUE TO A DEVICE DEFICIENCY. THE USER STATED THAT THE DISEASE DID NOT CAUSE THE EVENT, NOR DID ANY OTHER CONDITION OR CIRCUMSTANCE. THE FISTULA WAS TREATED WITH AN ENDOVASCULAR COIL EMBOLIZATION. THE PATIENT RECOVERED WITHOUT SEQUELAE, AND THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED TO HOME FOURTEEN DAYS AFTER THE EVAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418607 DQX WIRE, GUIDE, CATHETER DQX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention BEGRAFT PLUS 6 MM X 38 MM.| BEGRAFT PLUS 6 MM X 58 MM.| BEGRAFT PLUS 6 MM X 58 MM.| BEGRAFT PLUS 8 MM X 57 MM.| BEGRAFT PLUS 8 MM X 57 MM.| COOK AAA-BIFURCATED-GRAFT LOT AC1144234.| COOK THORACO-ABDOMINAL-SIDE-BRANCH LOT AC1158865.| TERUMO WIRE GUIDE.| ZISL-16-77, LOT 15978640.| ZISL-20-77, LOT 15993161.