BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 9278951 · Received November 5, 2019

    Report

    Report Number
    1820334-2019-02776
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 18, 2019
    Report Date
    July 6, 2020
    Manufacturer
    COOK INC
    Product Code
    MMX
    UDI-DI
    00827002518360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: ELEMAR INTERNATIONAL FORWARDING, A DISTRIBUTOR FOR BRAZIL, INFORMED COOK ON 22OCT2019 OF AN INCIDENT INVOLVING AN INDY OTW VASCULAR RETRIEVER (INDY-8.0-35-100-40) FROM LOT 9831361. IT WAS NOTICED THAT UPON INSPECTION, THE PRIMARY PACKAGING WAS OBSERVED TO BE ALREADY OPEN. THE DISTRIBUTOR CLARIFIED THAT SHIPPING CONTAINER ARRIVED UNDAMAGED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL OF THE DEVICE, AS WELL AS AN INTERVIEW OF PERSONNEL, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, THE DISTRIBUTOR PROVIDED PHOTOS OF THE DEVICE TO COOK. THE PHOTOS SHOW A COMPROMISE IN THE SEAL OF THE PACKAGING ALONG THE SIDE NEAR WHERE THE TYVEK MATERIAL SEALS TO THE CLEAR COVER. THERE IS OBJECTIVE EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THIS PRODUCT IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT (9831361) REVEALED NO NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. THE CALIBRATION TEAM LEAD WAS CONTACTED AS A RESULT OF THIS EVENT. CALIBRATION RECORDS OF THE ASSOCIATED SEALER INDICATE THAT THE CALIBRATION WAS UP-TO-DATE AT THE TIME OF MANUFACTURE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T INDYOTW REV 2 ¿INDY OTW VASCULAR RETRIEVER,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: "VISUALLY INSPECT THE PRODUCT BEFORE USE TO ENSURE IT IS UNDAMAGED." HOW SUPPLIED: ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE REPORTED EVENT WAS ATTRIBUTED TO TRANSPORT/STORAGE I.E. SHIPPING DAMAGE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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 PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: UNKNOWN. PMA/510(K) #: K160593. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSPECTION AT A DISTRIBUTION CENTER, THE PRIMARY PACKAGING OF A INDY OTW VASCULAR RETRIEVER WAS OBSERVED TO BE OPEN. THE SHIPPING CONTAINER FOR THE COMPLAINT DEVICE ARRIVED TO THE DISTRIBUTION CENTER UNDAMAGED. THE DAMAGE TO THE PACKAGING WAS VERIFIED AS SOON AS THE PRODUCT WAS REMOVED FORM THE SHIPPING CONTAINER. IT WAS THEN IDENTIFIED AS A NONCONFORMING PRODUCT AND STORED IN A DIFFERENT LOCATION. NO PATIENT CONTACT WAS MADE AND NO ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074497 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC N/A 9831361 00827002518360

    Patients

    Seq Age Sex Outcome Treatment
    1