BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSEN AMPLATZ EXTRA STIFF WIRE GUIDE

    MDR report key: 8603359 · Received May 13, 2019

    Report

    Report Number
    1820334-2019-01200
    Event Type
    Injury
    Date Received
    May 13, 2019
    Report Date
    August 28, 2019
    Manufacturer
    COOK INC
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, 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. REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THAT OUR REVIEWS REVEALED NO GAPS IN THE MANUFACTURING PROCESS, INVESTIGATION HAS CONCLUDED THAT THIS EVENT WAS NOT CAUSED BY THE DEVICE, BUT BY THE NATURE OF THE PROCEDURE. 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

    PRODUCT CODE: DQX. PMA/510K: PREAMENDMENT. (B)(4). 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

    A JOURNAL ARTICLE WAS REVIEWED WHERE REPORTEDLY A COOK J-TIPPED AMPLATZ EXTRA STIFF WIRE GUIDE WAS USED DURING A VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION PROCEDURE. ACCORDING TO THE ARTICLE, THERE WERE NO DEATHS AS A DIRECT RESULT OF COMPLICATIONS OF CANNULATION. THE COMPLICATIONS RECORDED AT INSERTION INCLUDED ONE CARDIAC FLUID BUILD UP, SECONDARY TO A GUIDEWIRE PERFORATING THE RIGHT VENTRICLE, WHICH OCCURRED IN CASE 15. DURING CANNULATION, THE WIRE WAS NOTED TO BE CURLED IN THE RIGHT VENTRICLE AND WAS WITHDRAWN. THERE WAS NO EVIDENCE OF CONTRAST MIGRATING OUTSIDE OF THE DESIGNATED LOCATIONS AFTER CANNULATION. THE CARDIAC FLUID BUILD UP WAS DIAGNOSED 6 HOURS LATER WITH THE EVIDENCE OF CARDIOGENIC SHOCK AND ECHOCARDIOGRAPHIC FEATURES OF FLUID BUILD UP. THIS EXCESS FLUID WAS REMOVED USING A PERCUTANEOUS PERICARDIAL DRAIN, CESSATION OF ANTICOAGULATION, AND BLOOD WAS RETURNED TO THE PATIENT AFTERWARD. THE DRAIN WAS REMOVED 24 HOURS LATER, NO PART OF THE DEVICE WAS LEFT IN THE PATIENT, AND THERE WERE NO LASTING ADVERSE EFFECTS. PROCEDURE: VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV-ECMO) CITATION: JANIS BURNS, EVE COOPER, GAVIN SALT, STUART GILLON, LUIGI CAMPOROTA, KATHLEEN DALY, AND NICHOLAS A. BARRETT. 'RETROSPECTIVE OBSERVATIONAL REVIEW OF PERCUTANEOUS CANNULATION FOR EXTRACORPOREAL MEMBRANE OXYGENATION.' ASAIO JOURNAL 2016; 62:325-328.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396562 ROSEN AMPLATZ EXTRA STIFF WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention