BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 6493509 · Received April 14, 2017

    Report

    Report Number
    1820334-2017-00360
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    March 15, 2017
    Report Date
    September 19, 2017
    Manufacturer
    COOK INC
    Product Code
    MMX
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED, MEASURED, AND TESTED. RESIDUAL ELONGATION OF THE CATHETER (PLASTIC DEFORMATION) BEYOND THE SPECIFIED CATHETER LENGTH WAS EVIDENT UPON VISUAL INSPECTION. THE CATHETER¿S DIAMETER CHANGES AS A FUNCTION OF THE CATHETER LENGTH. BASED ON THE REDUCTION IN DIAMETER OF THE CATHETER AND INCREASE IN LENGTH IT IS EVIDENT THAT THE DEVICE HAD BEEN STRETCHED. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE COMPLAINT LOT NUMBER WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION, INSPECTION OF RETURNED PRODUCT AND THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE COULD NOT CONCLUSIVELY BE DETERMINED. MEASURES WERE INITIATED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). PMA/510(K) # K160593. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT ILIAC ARTERY PROCEDURE USING AN INDY OTW VASCULAR RETRIEVER, THE INDY SNARE WAS INTRODUCED INTO THE RIGHT ILIAC ARTERY THROUGH ANOTHER MANUFACTURER'S DEVICE OVER AN AMPLATZ WIRE. THE SNARE WAS BEING USED TO SNARE A GLIDE WIRE FROM THE CONTRALATERAL (LEFT) ILIAC ARTERY. THE GLIDE WIRE HAD BEEN SNARED AND WAS BEING RETRIEVED INTO THE SHEATH ON THE RIGHT (IPSILATERAL) SIDE WHEN THE SNARE HUNG UP. THE PHYSICIAN STATED HE THEN ADJUSTED THE SNARE AND TRIED TO RETRIEVE THE SNARE WITH THE SNARED GLIDE WIRE INTO THE SHEATH. THE PHYSICIAN REPORTED THAT HE WAS PULLING A LITTLE HARDER, BUT NOT A LOT WHEN THE SNARE DISENGAGED FROM THE HANDLE (HANDLE -WIRE-SHEATH). ANOTHER MANUFACTURER'S SNARE WAS USED TO RETRIEVE THE DIS-ENGAGED SNARE OF THE INDY SNARE. AFTER THE SNARE WAS REMOVED THE PROCEDURE CONTINUED WITH NO ILL EFFECT TO THE PATIENT DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275757 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention