BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    MDR report key: 10648857 · Received October 8, 2020

    Report

    Report Number
    3002808486-2020-00937
    Event Type
    Injury
    Date Received
    October 8, 2020
    Report Date
    February 11, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DQX
    UDI-DI
    00827002454088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF#: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: FOR AORTIC VALVE REPLACEMENT THE GUIDE WIRE WAS ADVANCED RETROGRADE ACROSS THE AORTIC VALVE TO LEFT VENTRICULAR APEX. AFTER DELIVERY OF BALLOON AORTIC VALVULOPLASTY THE WIRE WAS NOTED TO HAVE AN ABNORMAL BAND APPROX. 40MM FROM DISTAL TIP AND WAS EXCHANGED FOR A NEW WIRE. THE WIRE APPEARED TO BE SLIGHTLY BENT, BUT AN ECHO NOTED A PERICARDIAL EFFUSION. SUBXIPHILD PERICARDIAL WINDOW FOLLOWED BY STERNOTOMY, CARDIOPULMONARY BYPASS, AND REPAIR OF LEFT VENTRICULAR PERFORATION. PER OR REPORT, THERE WAS A 1 CM LACERATION NEAR THE DISTAL END OF THE CIRCUMFLEX NEAR THE APEX. NO PRODUCT WAS RETURNED AND NO IMAGING COULD BE OBTAINED. THEREFORE, BASED ON THE INFORMATION PROVIDED IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE REPORTED 1CM LACERATION AND THE NEED FOR LEFT VENTRICULAR REPAIR, NOR IF THE WIRE GUIDE HAD ANY IMPACT. THE INSTRUCTIONS FOR USE NOTE THAT ALL WIRE GUIDE MOVEMENTS IN THE VESSEL MUST BE OBSERVED UNDER FLUOROSCOPY AND THAT THE WIRE GUIDE SHOULD BE ADVANCED ONLY WHEN VISUALIZING THE TIP OF THE WIRE GUIDE FLUOROSCOPICALLY. HOWEVER, IT IS NOTED THAT THE WIRE GUIDE WAS EXCHANGED AND FOUND BENT, BUT WITH NO EVIDENCE OF DISRUPTION OF THE OUTER CORE. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE FINAL RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    MANUFACTURERS REF# (B)(4). PMA/510(K) : K171513. CORRECTED DATA COMPARED WITH MW0700280000-2020-8016. OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). DATE OF EVENT: (B)(6) 2020. LUNDERQUIST; WIRE, GUIDE, CATHETER; (B)(6). LOT# 3842965; APR2024. RISK MANAGER. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO MEDWATCH 0700280000-2020-8016: PATIENT WAS UNDERGOING NON-SURGICAL AORTIC VALVE REPLACEMENT (AVR) WITH A 26MM COREVALVE. USING A RETROGRADE PERCUTANEOUS APPROACH FOR A TRANSCATHETER AORTIC VALVE. A 035/180CM LUNDERQUIST EXTRA STIFF WIRE WAS ADVANCED RETROGRADE ACROSS THE AORTIC VALVE TO THE LEFT VENTRICULAR APEX. AFTER THE DELIVERY OF THE BALLOON AORTIC VALVULOPLASTY, THE LUNDERQUIST WIRE WAS NOTED TO HAVE A ABNORMAL BAND APPROXIMATELY 40MM FROM THE DISTAL TIP AT THE SEGMENT OF THE WIRE THAT IS GENERALLY BONDED. AT THIS POINT THE PHYSICIAN BECAME CONCERNED GIVEN THE ABNORMAL APPEARANCE OF THE WIRE FOR TRAUMA TO THE LEFT VENTRICLE. A STRAIGHT PIGTAIL WAS DELIVERED, AND THE WIRE WAS EXCHANGED FOR A NEW ONE. THE INITIAL WIRE WAS EXAMINED, AND THERE WAS NO EVIDENCE OF DISRUPTION OF THE OUTER CORE, IT JUST SIMPLE APPEARED TO HAVE BENT SLIGHTLY. IN CAUTION, AN ECHO WAS PERFORMED, AND IT WAS NOTED FOR A PERICARDIAL EFFUSION, PATIENT WAS STABLE DURING PROCEDURE, CONSULT PLACED TO CV SURGEON, PATIENT BROUGHT TO OR FOR SUBXIPHILD PERICARDIAL WINDOW FOLLOWED BY STERNOTOMY, CARDIOPULMONARY BYPASS, AND REPAIR LEFT VENTRICULAR PERFORATION. PER OR REPORT, THERE WAS A 1 CM, LACERATION NEAR THE DISTAL END OF THE CIRCUMFLEX NEAR THE APEX. PATIENT OUTCOME: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111945 LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX WILLIAM COOK EUROPE G45408 E3842965 00827002454088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention