BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 12522153 · Received September 23, 2021

    Report

    Report Number
    1820334-2021-02209
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Report Date
    January 5, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002441545
    PMA / PMN Number
    K142829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, UPON COMPLETION OF A SUPERFICIAL FEMORAL ARTERY INTERVENTION, THE HUB SEPARATED FROM A FLEXOR ANSEL GUIDING SHEATH WHILE IT WAS BEING REMOVED. THE SHEATH HAD BEEN ADVANCED THROUGH THE RIGHT FEMORAL ARTERY TO THE LEFT EXTERNAL ILIAC. THE PATIENT'S ANATOMY WAS NOTED TO BE SCARRED AND CALCIFIED, AND RESISTANCE WAS REPORTED DURING INSERTION AND REMOVAL OF THE DEVICE. THE SHEATH WAS IN PLACE FOR ABOUT AN HOUR. THE DILATOR WAS NOT INSERTED INTO THE SHEATH WHEN THE DEVICE WAS REMOVED. FOLLOWING THE HUB SEPARATION, THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT FURTHER ISSUE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. THE COMPLAINANT RETURNED ONE USED FLEXOR ANSEL GUIDING SHEATH (KCFW-6.0-18/38-45-RB-ANL0-HC) TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED THE SHEATH SEPARATED FROM HUB. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED THE PRODUCT LABELING. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS ¿REINSERTION OF 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 OF FLEXOR SHEATH, CONSIDER CAREFULLY REINSERTING THE DILATOR PRIOR TO CONTINUING REMOVAL.¿ HOW SUPPLIED ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ COOK HAS CONCLUDED THAT THE FORCE REQUIRED TO REMOVE THE DEVICE DUE TO PATIENT ANATOMY CONTRIBUTED TO THIS INCIDENT DUE TO THE NOTED SCARED AND CALCIFIED ANATOMY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION: LEAD IMAGING TECH. 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, UPON COMPLETION OF A SUPERFICIAL FEMORAL ARTERY INTERVENTION, THE HUB SEPARATED FROM A FLEXOR ANSEL GUIDING SHEATH WHILE IT WAS BEING REMOVED. THE SHEATH HAD BEEN ADVANCED THROUGH THE RIGHT FEMORAL ARTERY TO THE LEFT EXTERNAL ILIAC. THE PATIENT'S ANATOMY WAS NOTED TO BE SCARRED AND CALCIFIED, AND RESISTANCE WAS REPORTED DURING INSERTION AND REMOVAL OF THE DEVICE. THE SHEATH WAS IN PLACE FOR ABOUT AN HOUR. THE DILATOR WAS NOT INSERTED INTO THE SHEATH WHEN THE DEVICE WAS REMOVED. FOLLOWING THE HUB SEPARATION, THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT FURTHER ISSUE. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416182 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G44154 14040394 00827002441545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown