BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 9873775 · Received March 24, 2020

    Report

    Report Number
    1820334-2020-00674
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Report Date
    March 24, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. INVESTIGATION - EVALUATION. BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY, INVESTIGATION HAS CONCLUDED THAT, WHILE A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED, THE DEVICE FAILURE CAN POTENTIALLY BE ATTRIBUTED TO THE PATIENT'S REPORTEDLY SCARRED ACCESS SITE. 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

    ADDITIONAL INFORMATION RECEIVED 25MAR2020. AS REPORTED, ACCESS WAS OBTAINED INTO A SCARRED FEMORAL ARTERY. RESISTANCE WAS FELT DURING REMOVAL OF THE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K171275. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. A DOCUMENT REVIEW WAS COMPLETED AS A RESPONSE TO THIS EVENT. A DEVICE MASTER RECORD REVIEW WAS PERFORMED, INCLUDING DEVICE SPECIFICATIONS, DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR NON-CONFORMANCES WAS NOT POSSIBLE DUE TO THE LOT NUMBER NOT BEING PROVIDED. A COMPLAINT SEARCH FOR COMPLAINTS ON THE SAME LOT WAS NOT POSSIBLE DUE TO THE LOT NUMBER NOT BEING PROVIDED. THE DEVICE HISTORY FILE WAS REVIEWED, AND RISK CONTROLS ARE IN PLACE FOR THIS FAILURE MODE. DUE TO PHOTOS OF THE DEVICE NOT BEING PROVIDED AND THE DEVICE WAS NOT RETURNED, A COMPLETE DEVICE FAILURE ANALYSIS WAS NOT PERFORMED. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE PROVIDES EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND AN UNCONFIRMED LOT NUMBER, INVESTIGATION HAS CONCLUDED THAT A CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. THE COMPLAINT WILL BE CONFIRMED BASED ON CUSTOMER TESTIMONY. THIS CASE WAS EVALUATED FOR RISK AND NO ADDITIONAL RISK MITIGATION ACTIVITY IS RECOMMENDED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. 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

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED FROM THE INTRODUCER UPON REMOVAL OF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338186 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1