BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR SHUTTLE SELECT GUIDING SHEATH

    MDR report key: 9680977 · Received February 7, 2020

    Report

    Report Number
    1820334-2020-00303
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    January 19, 2020
    Report Date
    April 30, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002311381
    PMA / PMN Number
    K153430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, DURING PLACEMENT OF AN UNKNOWN STENT INVOLVING THE CAROTID ARTERY, A FLEXOR SHUTTLE SELECT GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. AS THE USER ATTEMPTED TO EXCHANGE THE SHEATH FOR AN ALTERNATE APPROACH, IT UNRAVELED AT THE END AS IT WAS PULLED OUT. AN UNKNOWN WIRE GUIDE WAS UTILIZED DURING THE PROCEDURE. DETAILS OF THE PATIENT'S ANATOMY ARE UNKNOWN. IT IS UNKNOWN IF THE DILATOR OR ANY OTHER DEVICE WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF THE EVENT. RESISTANCE WAS NOT REPORTED DURING INSERTION OR REMOVAL OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SHEATH AND THE PATIENT WAS REPORTEDLY STABLE. 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. INVESTIGATION EVALUATION: A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, EXAMINATION OF THE DEVICE WAS NOT POSSIBLE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND MANUFACTURING DOCUMENTS PROVIDE OBJECTIVE EVIDENCE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. THE QUALITY CONTROL, MANUFACTURING, AND WORK INSTRUCTIONS CONTAIN ADEQUATE MEASURES TO ADDRESS THE FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT LABELING PROVIDES WARNINGS AND PRECAUTIONS FOR USERS RELATED TO THE FAILURE MODE. THERE WERE NO GAPS IDENTIFIED IN THE MANUFACTURING OR QUALITY CONTROL PROCESSES. THE PRODUCT IFU WARNS THE USER: "IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OF FLEXOR SHEATH, ASSESS CAUSE OF RESISTANCE AND CONSIDER DILATION OF ANY RESTRICTION IDENTIFIED OR CONSIDER ALTERNATE TREATMENT STRATEGY. IF FLEXOR SHEATH IS ADVANCED THROUGH RESISTANCE, FORCE TO REMOVE THE SHEATH WILL BE HIGHER, INCREASING THE RISK OF SHEATH MATERIAL OR HUB SEPARATION UPON WITHDRAWAL." THE IFU ALSO STATES: "REINSERTION OF THE DILATOR PRIOR TO REMOVAL OF FLEXOR SHEATH INCREASES THE STRENGTH OF THE SHEATH AND LESSENS THE RISK OF DEVICE SEPARATION. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OR FLEXOR SHEATH, CONSIDER CAREFULLY REINSERTING THE DILATOR PRIOR TO CONTINUING REMOVAL." BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED; HOWEVER, BASED ON THE MANUFACTURING REVIEW THERE IS NO EVIDENCE TO SUGGEST MANUFACTURING ISSUES WERE AT FAULT. IT IS POSSIBLE THAT ANATOMICAL FACTORS OR ANCILLARY DEVICE INTERACTION MAY HAVE PLAYED A ROLE IN THIS FAILURE; HOWEVER, THIS CANNOT BE CONFIRMED AS THE DETAILS WERE UNKNOWN. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION = NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K153430. 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 PLACEMENT OF AN UNKNOWN STENT INVOLVING THE CAROTID ARTERY, A FLEXOR SHUTTLE SELECT GUIDING SHEATH UNRAVELED UPON REMOVAL OF THE DEVICE. AS THE USER ATTEMPTED TO EXCHANGE THE SHEATH FOR AN ALTERNATE APPROACH, IT UNRAVELED AT THE END AS IT WAS PULLED OUT. AN UNKNOWN WIRE GUIDE WAS UTILIZED DURING THE PROCEDURE. DETAILS OF THE PATIENT'S ANATOMY ARE UNKNOWN. IT IS UNKNOWN IF THE DILATOR OR ANY OTHER DEVICE WAS IN THE LUMEN OF THE SHEATH AT THE TIME OF THE EVENT. RESISTANCE WAS NOT REPORTED DURING INSERTION OR REMOVAL OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SHEATH AND THE PATIENT WAS REPORTEDLY STABLE. 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
    144288 FLEXOR SHUTTLE SELECT GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G31138 9911929 00827002311381

    Patients

    Seq Age Sex Outcome Treatment
    1