BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 6508191 · Received April 20, 2017

    Report

    Report Number
    1820334-2017-00686
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    March 23, 2017
    Report Date
    October 6, 2017
    Manufacturer
    COOK INC
    Product Code
    MMX
    UDI-DI
    00827002518360
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # K160593. THE DEVICE HAS BEEN REQUESTED AND NOT YET RECEIVED. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION. A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL DATA, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE SAMPLES WERE VISUALLY INSPECTED, MEASURED, AND TESTED. THE ASSOCIATED MANUFACTURING PROCESS WORK INSTRUCTIONS AND LOT RECORDS WERE REVIEWED. ALL IN-HOUSE MATERIAL AND PRODUCT WAS EVALUATED. THE INVESTIGATION SHOWS THAT RUPTURE OF THIS CATHETER ALSO OCCURRED. TEARING OF THE SNARE FROM THE CATHETER TOOK PLACE OUTSIDE OF THE JOINING AREA WHERE THE CATHETER WAS GLUED TO THE SNARE¿S STRANDS. FROM THE PICTURE, IT IS CLEAR THAT DESTRUCTION OF THE CATHETER TOOK PLACE AT A DISTANCE ABOUT 1MM BELOW WHERE THE SUTURE STILL WAS WRAPPED AROUND OF THE CATHETER AND GLUED TO IT. THE ROUGHED-UP AREA OF THE CATHETER WAS NOT SEEN. JUST A SMOOTH SURFACE OF THE CATHETER AND ITS BROKEN END WAS NOTED. THE MEASURED LENGTH OF THE CATHETER FROM THE BREAKAGE POINT TO THE DISTAL END OF THE HANDLE CANNULA SHOWS THAT ELONGATION OF THE CATHETER (PLASTIC DEFORMATION) IS ABOUT 4%. IN ORDER TO SEE THE PLASTIC DEFORMATION OF THE CATHETER, ITS DIAMETER CHANGES AS A FUNCTION OF THE CATHETER LENGTH WAS MEASURED. FROM THIS, IT WAS SEEN THAT THE FORCE, WHICH WAS APPLIED TO THE DEVICE DURING ITS USE LED TO PLASTIC DEFORMATION OF THE CATHETER, ESPECIALLY IN THE AREA LOCATED AT A DISTANCE ABOUT 125MM FROM THE BREAKAGE POINT. HOWEVER, IN THIS CASE THE CATHETER DID NOT RECEIVE SIGNIFICANT ELONGATION IN COMPARISON WITH ITS INITIAL LENGTH, ALTHOUGH THE DIAMETER CHANGES SHOW THE IMPACT OF THE FORCE APPLIED. WE ALSO FOUND THAT THIS CATHETER WAS KINKED AND DEFORMED IN THE AREA NEAR THE HANDLE CANNULA DISTAL END, BUT IT IS NOT CLEAR WHERE IT HAPPENED: DURING USE OR DURING TRANSPORTATION AND HANDLING DURING RETURN. THE EVALUATIONS CONDUCTED UPON REPRESENTATIVE PRODUCTS MANUFACTURED FOLLOWING APPROVED PROCESSES REVEALED THAT THE PRODUCTS COMPLIED WITH ALL PREDEFINED ACCEPTANCE CRITERIA AND THAT THE FAILURE MODES COULD ONLY BE DUPLICATED AT FORCES (TENSILE) GREATER THAN THE DEFINED ACCEPTANCE CRITERIA, SUGGESTING THAT EXCESSIVE FORCES MAY HAVE BEEN APPLIED TO THE UNITS, CAUSING THE FAILURES IDENTIFIED. HOWEVER, BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE ON FOLLOW-UP 1 SHOULD BE 10/06/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA (IVC) RETRIEVAL PROCEDURE USING AN INDY OTW VASCULAR RETRIEVER, THE ENTIRE TIP OF THE INDY OTW VASCULAR RETRIEVER BROKE OFF AND VENTURED INTO THE VENTRICLE. WITH THE USE OF ANOTHER MANUFACTURER'S DEVICE, THE PHYSICIAN WAS ABLE TO RETRIEVE ALL PIECES OF THE INDY OTW VASCULAR RETRIEVER. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289535 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC N/A 00827002518360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention