BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 17991427 · Received October 23, 2023

    Report

    Report Number
    1820334-2023-01427
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 2, 2023
    Report Date
    January 30, 2024
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K142829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ADDITIONAL/CORRECTED INFORMATION: D1, D4, D9, H3. D1, D4: ALTHOUGH THE CUSTOMER INITIALLY REPORTED THAT THE COMPLAINT DEVICE WAS A KSAW-7.0-18/38-55-RB-ANL1-HC, A PHOTO OF THE DEVICE PROVIDED BY THE CUSTOMER SHOWS A KCF- DEVICE INSTEAD OF THE REPORTED KSAW- DEVICE. ADDITIONALLY, SALES RECORDS DO NOT SHOW THAT THIS CUSTOMER HAS PURCHASED A KSAW- DEVICE IN THE LAST THREE YEARS. SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF THE LEG WITH REMOVAL OF ARTERIAL THROMBUS, A FLEXOR ANSEL GUIDING SHEATH'S HUB BROKE. THE PATIENT PRESENTED WITH CALCIFICATION OF THE SUPERFICIAL FEMORAL ARTERY. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY FOR A CONTRALATERAL APPROACH. THE ACCESS SITE WAS NOT SCARRED. THE ANATOMY WAS CALCIFIED BUT NOT VERY TORTUOUS, AND THE BIFURCATION WAS ACUTE. OTHER MANUFACTURERS' WIRE GUIDES WERE USED THROUGH THE SHEATH DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER'S DRUG COATED BALLOON AND THROMBECTOMY DEVICE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH, OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. AS THE THROMBECTOMY DEVICE WAS BEING REMOVED FROM THE SHEATH, THE CAP BROKE OFF OF THE SHEATH'S HUB. REPORTEDLY, IT WAS DIFFICULT TO CONTROL BLEEDING; HOWEVER, THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. THE SHEATH WAS REMOVED, AND ANOTHER 7-FRENCH ANSEL SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. 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: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION; HOWEVER, A PHOTO WAS PROVIDED. THE PHOTO SHOWS A KCF- DEVICE INSTEAD OF THE REPORTED KSAW- DEVICE. THE CAP OF THE DEVICE WAS SEPARATED FROM THE REST OF THE CHECK-FLO ASSEMBLY. THE SUPPLIER OF THE CHECK-FLO ASSEMBLY WAS NOTIFIED. THE LOT NUMBER WAS NOT PROVIDED TO COOK, AND A SEARCH OF SALES COULD NOT DEFINITIVELY DETERMINE THE LOT; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES ¿ALL INTERVENTIONAL OR DIAGNOSTIC INSTRUMENTS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH TO AVOID DAMAGE.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, IFU, CUSTOMER TESTIMONY, AND DEVICE PHOTO SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE, UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES, CONTRIBUTED TO THIS EVENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Description of Event or Problem · 0

    AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF THE LEG WITH REMOVAL OF ARTERIAL THROMBUS, A FLEXOR ANSEL GUIDING SHEATH'S HUB BROKE. THE PATIENT PRESENTED WITH CALCIFICATION OF THE SUPERFICIAL FEMORAL ARTERY. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY FOR A CONTRALATERAL APPROACH. THE ACCESS SITE WAS NOT SCARRED. THE ANATOMY WAS CALCIFIED BUT NOT VERY TORTUOUS, AND THE BIFURCATION WAS ACUTE. OTHER MANUFACTURERS' WIRE GUIDES WERE USED THROUGH THE SHEATH DURING THE PROCEDURE, AS WELL AS ANOTHER MANUFACTURER'S DRUG COATED BALLOON AND THROMBECTOMY DEVICE. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH, OR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. AS THE THROMBECTOMY DEVICE WAS BEING REMOVED FROM THE SHEATH, THE CAP BROKE OFF OF THE SHEATH'S HUB. REPORTEDLY, IT WAS DIFFICULT TO CONTROL BLEEDING; HOWEVER, THE PATIENT DID NOT REQUIRE TREATMENT FOR BLOOD LOSS. THE SHEATH WAS REMOVED, AND ANOTHER 7-FRENCH ANSEL SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. 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
    1949386 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ABBOTT SUPRACORE, TERUMO GUIDEWIRE.| PNEUMBRA LIGHTNING 7 130CM.