BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQX WIRE, GUIDE, CATHETER

    MDR report key: 8571812 · Received May 1, 2019

    Report

    Report Number
    1820334-2019-01024
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    July 2, 2019
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL WERE 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, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. IF SHOULD BE NOTED THAT THERE IS NO IFU INCLUDED WITH THIS DEVICE. IT IS UNKNOWN WHAT SHEATH WAS USED DURING THIS PROCEDURE, OR IF THE SHEATH WAS MANUALLY SHORTENED. IT IS ALSO UNKNOWN IF THE WIRE GUIDE WAS ALTERED PRIOR TO USE. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS 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

    DEVICE NAME = UNKNOWN. PRODUCT CODE = DQX. RPN AND LOT NUMBER ARE UNKNOWN. PMA/510(K) NUMBER = PRE-AMENDMENT. CITATION: ALLEN K, CHHATRIWALLA A, COHEN D, SAXON J, HAWA Z, KENNEDY K, AGGARWAL S, DAVIS R, PAK A, BORKON AM, TRANSCAROTID VERSUS TRANSAPICAL AND TRANSAORTIC ACCESS FOR TRANSCATHETER AORTIC VALVE REPLACEMENT, THE ANNALS OF THORACIC SURGERY (2019), DOI: HTTPS://DOI.ORG/10.1016/ J.ATHORACSUR.2019.02.007. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION OR, WHEN ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. [(B)(4)].

    Description of Event or Problem · 1

    A LITERATURE REVIEW OF THE ARTICLE "TRANSCAROTID VERSUS TRANSAPICAL AND TRANSAORTIC ACCESS FOR TRANSCATHETER AORTIC VALVE REPLACEMENT, THE ANNALS OF THORACIC SURGERY", REVEALED DURING A TRANSAORTIC VALVE REPLACEMENT (TAVR) PROCEDURE: "THE AORTIC VALVE IS CROSSED IN A STANDARD FASHION, HEMODYNAMICS MEASUREMENTS ARE THEN OBTAINED AND AN AMPLATZ EXTRA STIFF (COOK MEDICAL, BLOOMINGTON, IN) WIRE IS INSERTED INTO THE LEFT VENTRICLE." LATER, THE ARTICLE DISCUSSES COMPLICATIONS ARISING FROM THE TVAR PROCEDURE, INCLUDING: "...LEFT VENTRICULAR WIRE PERFORATION OCCURRED IN ONE PATIENT THAT WAS MANAGED WITH A SUBXIPHOID PERICARDIAL WINDOW." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361140 DQX WIRE, GUIDE, CATHETER DQX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R