BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPROACH CTO MICROWIRE WIRE GUIDE

    MDR report key: 13094625 · Received December 28, 2021

    Report

    Report Number
    1820334-2021-02739
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    November 13, 2021
    Report Date
    April 6, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002507937
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME & PRODUCT CODE = DQX, PDU. PMA/510(K) NUMBER = K171897. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5. EVENT SUMMARY AS REPORTED VIA A MEDWATCH REPORT, AN APPROACH CTO MICROWIRE WIRE GUIDE KINKED AND BECAME STUCK IN THE VESSEL. ACCESS WAS GAINED THROUGH THE RIGHT COMMON FEMORAL ARTERY UP-AND-OVER THE BIFURCATION INTO THE LEFT POSTERIOR TIBIAL ARTERY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. THE DEVICE COULD NOT BE WITHDRAWN FROM THE PATIENT AFTER ANGIOPLASTY OF THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES HAD BEEN PERFORMED. AN UNKNOWN 6 FRENCH CATHETER WAS ADVANCED IN AN ATTEMPT TO STRAIGHTEN THE KINK IN THE WIRE; HOWEVER, THIS WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED FROM THE PATIENT UNDER DIRECT VISUALIZATION VIA LEFT FEMORAL ARTERIOTOMY. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT. INVESTIGATION - EVALUATION REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE USED AND DAMAGED APPROACH CTO MICROWIRE WIRE GUIDE WAS RECEIVED IN SEVERAL PIECES ALONG WITH A BALLOON CATHETER LODGED ON THE WIRE GUIDE. SUBSEQUENT PHYSICAL EVALUATION OF THE DEVICE BY THE SUPPLIER OBSERVED THE DEVICE WAS CUT AT APPROXIMATELY 710MM AND 810MM FROM THE TIP, WITH THE DISTAL SEGMENT INSERTED INTO A BALLOON CATHETER. EACH SEGMENT SHOWED EVIDENCE OF HAVING BEEN CUT BY AN EDGED TOOL. THE MIDDLE SEGMENT CONTAINED A LOOPED DEFORMATION WITH A KINK. THE PROXIMAL SEGMENT SHOWED PEELED TFE COATING OVER THE ENTIRE LENGTH OF THE SEGMENT. THE DISTAL SEGMENT¿S INNER WAS EXPOSED FROM THE OUTER WIRE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCE'S WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. AN INVESTIGATION WAS ALSO CONDUCTED BY THE SUPPLER OF THE DEVICE. THE SUPPLIER REVIEWED MANUFACTURING RECORDS AND CONCLUDED THERE IS NO ISSUE LEADING TO THIS DEFECT AND NO ISSUES BEFORE SHIPMENT OF PRODUCT. IT IS POSSIBLE THE WIRE GUIDE WAS KINKED DUE TO EXCESSIVE BENDING WHILE BEING LOADED AND WHILE CONTINUING TO USE THE DEVICE IT BECAME MORE KINKED. THE SUPPLIER CONCLUDED THAT THE PEELING TFE COATING WAS POSSIBLY FROM EXCESSIVE LOADING DUE TO TOUCHING A TORQUER OR MATERIAL INSERTER, BUT A CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH PROVIDE THE FOLLOWING WARNINGS RELATED TO THE REPORTED FAILURE MODE: ¿THE WIRE GUIDE SHOULD BE ADVANCED ONLY WHEN VISUALIZING THE TIP OF THE WIRE GUIDE FLUOROSCOPICALLY. THE WIRE GUIDE SHOULD NOT BE TORQUED WITHOUT EVIDENCE OF CORRESPONDING MOVEMENT OF THE DISTAL TIP.¿ ¿ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE.¿ ¿EXCESSIVE TIGHTENING OF A TORQUE DEVICE MAY ABRADE THE COATING ON THE WIRE GUIDE.¿ BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING CONTRIBUTED TO THIS INCIDENT. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING 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

    AS REPORTED VIA A MEDWATCH REPORT, DURING AN UNSPECIFIED PROCEDURE, AN APPROACH CTO MICROWIRE WIRE GUIDE KINKED AND BECAME STUCK IN THE VESSEL. AN UNKNOWN ANGIOPLASTY BALLOON AND SHEATH WERE USED WITH THE WIRE. "PART WAY" THROUGH THE PROCEDURE, THE WIRE BENT AND WAS UNABLE TO BE WITHDRAWN FROM THE PATIENT. AN UNKNOWN 6 FRENCH CATHETER WAS ADVANCED IN AN ATTEMPT TO STRAIGHTEN THE KINK IN THE WIRE; HOWEVER, THIS WAS UNSUCCESSFUL. THE SURGEON THEN DECIDED TO PERFORM A CUT-DOWN OF THE LEFT GROIN TO AVOID DAMAGING THE VESSELS OR EQUIPMENT, AND THE WIRE WAS REMOVED UNDER DIRECT VISUALIZATION. THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 10MAR2022. ACCESS WAS GAINED THROUGH THE RIGHT COMMON FEMORAL ARTERY UP-AND-OVER THE BIFURCATION INTO THE LEFT POSTERIOR TIBIAL ARTERY. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, CALCIFIED, OR SCARRED. THE DEVICE COULD NOT BE WITHDRAWN FROM THE PATIENT AFTER ANGIOPLASTY OF THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES HAD BEEN PERFORMED. THE DEVICE WAS REMOVED FROM THE PATIENT VIA LEFT FEMORAL ARTERIOTOMY. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993250 APPROACH CTO MICROWIRE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G50793 14068800 00827002507937

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention