BEUDAMED
    FDA Adverse Event Death Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 8568995 · Received May 1, 2019

    Report

    Report Number
    1820334-2019-01001
    Event Type
    Death
    Date Received
    May 1, 2019
    Report Date
    July 3, 2019
    Manufacturer
    COOK INC
    Product Code
    DXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: REVIEWS OF THE DRAWINGS, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES ¿BEFORE WITHDRAWING THE SHEATH THROUGH TORTUOUS ANATOMY, INSERT THE INTRODUCER DILATOR TO AVOID POSSIBLE BREAKAGE. IN ADDITION, THE IFU STATES, ¿WITHDRAW THE SHEATH AND DILATOR AS A UNIT.¿ THE PHYSICIAN STATED THE DEVICE WAS STIFF GOING IN. THE IFU STATES, ¿DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT.¿ THERE IS NO INFORMATION REGARDING OTHER DEVICES USED IN THIS PROCEDURE OR IF THESE DEVICES MET THEIR MANUFACTURER¿S QUALITY SPECIFICATIONS. PER THE IFU, ¿UPON REMOVAL FROM PACKAGE, ENSURE THE INNER DIAMETER (ID) OF THE INTRODUCER IS APPROPRIATE FOR THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED.¿ ALSO, ¿THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE ITS PASSAGE THROUGH THE INTRODUCER. ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT.¿ BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, THE MOST PROBABLE CAUSES OF THIS EVENT ARE MEDICAL PROCEDURE, HUMAN ANATOMY AND/OR USER TECHNIQUE RELATED. MULTIPLE REQUESTS FOR FURTHER INFORMATION WERE MADE TO THE AUTHOR OF THE LITERATURE ARTICLE; HOWEVER, A RESPONSE WAS NOT RECEIVED. CONSEQUENTLY, INVESTIGATION CONCLUDED THAT A ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE 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. 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

    DATE OF DEATH: UNKNOWN. SUSPECT MEDICAL DEVICE: PRODUCT INFORMATION CURRENTLY UNAVAILABLE. COMMON DEVICE NAME: DEVICE IS DESCRIBED AS AN UNSPECIFIED "AMPLATZ EXTRA STIFF WIRE". CONCOMITANT MEDICAL PRODUCTS: COOK "DOUBLE CURVE LUNDERQUIST," CRYOLIFE BIOGLUE. INITIAL REPORTER ALSO SENT REPORT TO FDA: UNKNOWN. PMA/510(K): UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE BELOW EVENT DESCRIPTION WAS TAKEN FROM THE FOLLOWING MEDICAL GUIDE: WATKINS, A. CLAIRE, ANUJ GUPTA, AND BARTLEY P. GRIFFITH. ¿CHAPTER 16: INTERESTED AND COMPLICATED CASES.¿ TRANSCATHETER AORTIC VALVE REPLACEMENT: A HOW-TO GUIDE FOR CARDIOLOGISTS AND CARDIAC SURGEONS. SPRINGER (2018): 121-122. IT WAS STATED: "A (B)(6) MAN WITH SEVERE AORTIC STENOSIS AND STS RISK SCORE OF 13% AND HOSPITALIZED WITH HEART FAILURE WAS REFERRED FOR TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT). HE HAD NORMAL LEFT VENTRICULAR EJECTION FRACTION, MODERATE MR, AND A MEAN GRADIENT OF 48 MMHG. HIS CTA WAS CONSISTENT WITH A SAPIEN THV 26 MM VALVE. HE UNDERWENT CUTDOWN OF THE RIGHT GROIN, WITH THE DELIVERY SHEATH PLACED ON THAT SIDE OVER A DOUBLE CURVE LUNDERQUIST. AFTER CROSSING THE VALVE, AN AMPLATZ EXTRA STIFF WIRE WAS PLACED IN THE LV. AFTER BALLOON VALVULOPLASTY AT A RATE OF 160 BPM, THE VALVE WAS ADVANCED AND DEPLOYED. IMMEDIATELY AFTER DEPLOYMENT, TEE DEMONSTRATED NO AORTIC INSUFFICIENCY, BUT THE PATIENT REQUIRED INOTROPIC SUPPORT, FOLLOWED BY CPR, AND SUBSEQUENTLY PERIPHERAL CARDIOPULMONARY BYPASS. A PERICARDIAL EFFUSION WAS SEEN, AND A PERICARDIAL DRAIN WAS IMMEDIATELY PLACED. THE PATIENT UNDERWENT MEDIAN STERNOTOMY. A BLEEDING SITE WAS FOUND POSTERIORLY IN THE LV. A LV VENT WAS PLACED TO DECOMPRESS THE VENTRICLE, AND PLEDGETED SUTURES WERE PLACED AT THE SITE OF THE VENTRICULAR LACERATION, ALONG WITH BIOGLUE. THE CHEST WAS PACKED, AND THE PATIENT WAS TRANSFUSED WITH FRESH FROZEN PLASMA. THE PATIENT WAS DECANNULATED FROM THE BYPASS MACHINE. THE PATIENT SUBSEQUENTLY WAS FOUND TO HAVE INJURY OF THE HEPATIC VEIN AND PORTAL VEIN, AND DUE TO THE ADVANCED EXTENT OF INJURY, SUCCUMBED TO THE COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362308 DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death