BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 10853816 · Received November 17, 2020

    Report

    Report Number
    1820334-2020-02120
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 22, 2020
    Report Date
    March 4, 2021
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. DESCRIPTION OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB SEPARATED FROM AN UNSPECIFIED COOK 7 FRENCH, 55 CENTIMETER SHEATH UPON REMOVAL OF THE DEVICE. THE SHEATH WAS INSERTED INTO A TORTUOUS, CALCIFIED ARTERY AND WAS IN PLACE FOR ONE HOUR. THE DEVICE WAS USED WITH ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE. AS THE USER REMOVED THE SHEATH, THE HUB SEPARATED AND THE DEVICE SUBSEQUENTLY UNRAVELED. THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL OR SEPARATION. THE USER ADVANCED AN UNKNOWN BALLOON TO THE DISTAL PORTION OF THE SHEATH, INFLATED THE BALLOON, AND REMOVED THE DEVICE. THE PATIENT IS REPORTEDLY "FINE". NO ADDITIONAL INTERVENTIONS WERE REQUIRED. INVESTIGATION ¿ EVALUATION A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF DOCUMENTATION, DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. 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 MADE OUT OF SPECIFICATION. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. A CAPA WAS OPENED AS A RESULT OF A RIC. THIS RIC WAS INITIATED FOLLOWING AN INCREASE IN YEARLY COMPLAINTS OF PATIENT INJURY OR DEATH BETWEEN 2018 AND 2019. THESE EVENTS CORRESPOND TO AN INCREASE IN ALL COMPLAINTS FROM OCCURRENCE LEVEL OF REMOTE (2) TO OCCASIONAL (3). THE CAPA TEAM ASSESSED THE ROOT CAUSE TO BE THIN WALL OF PTFE LINER BEING SUSCEPTIBLE TO DAMAGE FROM HANDLING AND PROCESSING DURING PROFILING AND COIL TRANSFER PROCESSES LEADING TO INCREASED SUSCEPTIBILITY TO SHAFT SEPARATION. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. COOK ESTABLISHED ADVERSE EVENT RELATED TO PATIENT CONDITION AND PROCEDURE AS CAUSE FOR THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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 NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. (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

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE HUB SEPARATED FROM AN UNSPECIFIED COOK 7 FRENCH, 55 CENTIMETER SHEATH UPON REMOVAL OF THE DEVICE. THE SHEATH WAS INSERTED INTO A TORTUOUS, CALCIFIED ARTERY AND WAS IN PLACE FOR ONE HOUR. THE DEVICE WAS USED WITH ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE. AS THE USER REMOVED THE SHEATH, THE HUB SEPARATED AND THE DEVICE SUBSEQUENTLY UNRAVELED. THE DILATOR WAS NOT IN PLACE AT THE TIME OF REMOVAL OR SEPARATION. THE USER ADVANCED AN UNKNOWN BALLOON TO THE DISTAL PORTION OF THE SHEATH, INFLATED THE BALLOON, AND REMOVED THE DEVICE. THE PATIENT IS REPORTEDLY "FINE". NO ADDITIONAL INTERVENTIONS WERE REQUIRED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319249 DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC 2.4 JETSTREAM.