BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 23417371 · Received October 29, 2025

    Report

    Report Number
    1820334-2025-01343
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 18, 2022
    Report Date
    February 11, 2026
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002135390
    PMA / PMN Number
    K142819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PHONE = (B)(6). G4: 510(K) K142819 OR K153430. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, A3, B2, B3, B5, B7, D1, D4, D10, G4, H4, H6 (ANNEXES E & F). CORRECTED INFORMATION: G4, H6 (ANNEXES E & F). 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, UNSPECIFIED COOK FLEXOR SHUTTLE LONG SHEATHS WERE USED FOR THREE CASES INVOLVING PLACEMENT OF NEUROVASCULAR FLOW-DIVERTING STENTS WITHIN THE PAST SIX YEARS, AFTER WHICH THE PATIENTS DEVELOPED IATROGENIC GRANULOMATOUS INFLAMMATORY REACTIONS TO HYDROPHILIC COATING MATERIAL EMBOLIZATION. THE THREE CASES WILL BE REPORTED UNDER PATIENT IDENTIFIERS (B)(6). ANOTHER MANUFACTURER¿S CATHETERS WERE ALSO USED DURING THE PROCEDURES, AS WELL AS UNSPECIFIED STENTS. A FEW WEEKS AFTER THE PROCEDURES, THE PATIENTS DEVELOPED NEUROLOGICAL DEFICITS, SECONDARY TO MULTIPLE TINY NODULES OF INFLAMMATION IN THE AREA OF THE BRAIN SUPPLIED BY THE ARTERIES INVOLVED IN THE PROCEDURES. REPORTEDLY, THE USER BELIEVES THAT SOME OF THE COATING MATERIAL OF ANY OF THE DEVICES USED DURING THE PROCEDURES MAY HAVE DETACHED AND EMBOLIZED DISTALLY, CAUSING INFLAMMATION IN SENSITIVE PATIENTS. PER THE REPORTER, THE COATING OF THE UNKNOWN STENT IS NOT BELIEVED TO BE THE CULPRIT IN ALL THREE CASES, AS ONE CASE ALSO INVOLVED TERRITORY OF BRANCHES PROXIMAL TO THE LOCATION OF THE STENT. THE USER SUSPECTS THAT THE EMBOLIZED PARTICLES MAY HAVE ORIGINATED FROM THE SHEATH OR OTHER MANUFACTURER¿S GUIDING CATHETERS, WHICH ARE SUBJECT TO FRICTION DURING STENT DEPLOYMENT. THE PATIENTS WERE HOSPITALIZED. ADDITIONAL INFORMATION WAS RECEIVED 31OCT2025. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET A TORTUOUS LEFT POSTERIOR CEREBRAL ARTERY. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH, NOR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. SEPARATION OF HYDROPHILIC COATING WAS NOT VISIBLE. ANOTHER MANUFACTURER¿S STENT WAS USED DURING THE PROCEDURE. NEUROLOGICAL DEFICITS WERE NOT PRESENT BEFORE THE PROCEDURE. THE PATIENT DEVELOPED DIPLOPIA (DOUBLE VISION) AFTER THE PROCEDURE. THE NEUROLOGICAL DEFICITS HAVE RESOLVED, AND THE PATIENT REPORTEDLY HAS NOT EXPERIENCED ANY PERMANENT IMPAIRMENT OR PERMANENT DAMAGE DUE TO THE EVENT; HOWEVER, THE PATIENT REQUIRES CHRONIC IMMUNOSUPPRESSANTS, AS THE SYMPTOMS RECURRED AFTER CEASING THE INITIAL COURSE OF STEROIDS. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOUND NO DISCREPANCIES OR ADDITIONAL COMPLAINTS ON THE FINAL LOT. THE PRODUCT IFU CAUTIONS THAT ALL INTERVENTIONAL OR DIAGNOSTIC INSTRUMENTS USED WITH THE SHEATH SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH TO AVOID DAMAGE. POTENTIAL ADVERSE EFFECTS LISTED IN THE IFU INCLUDE, BUT ARE NOT LIMITED TO, DISTAL EMBOLIZATION, ISCHEMIA, STROKE, AND VASCULAR THROMBOSIS OR OCCLUSION. 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 CUSTOMER TESTIMONY, COMPLAINT FILE, IFU, DMR, AND DHR SUGGESTS THAT THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED AN ADVERSE EVENT RELATED TO THE PROCEDURE CONTRIBUTED TO THIS INCIDENT. PER THE REPORTER, THE INFLAMMATION WAS CAUSED BY EMBOLIZATION OF HYDROPHILIC MATERIAL; HOWEVER, SEPARATION OF HYDROPHILIC COATING WAS NOT VISIBLE, AND THE OTHER MANUFACTURER¿S CATHETERS USED DURING THE PROCEDURE WERE ALSO HYDROPHILICALLY COATED. THERE HAS BEEN NO SPECIFIC ALLEGATION THAT THE SHEATH¿S HYDROPHILIC COATING SEPARATED. RESISTANCE WAS NOT REPORTED DURING INSERTION OR REMOVAL OF THE SHEATH, NOR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH, WHICH SUGGESTS THAT FRICTION WAS NOT ENCOUNTERED WITH SHEATH USE. 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.

    Description of Event or Problem · 0

    AS REPORTED, UNSPECIFIED COOK FLEXOR SHUTTLE LONG SHEATHS WERE USED FOR THREE CASES INVOLVING PLACEMENT OF NEUROVASCULAR FLOW-DIVERTING STENTS WITHIN THE PAST SIX YEARS, AFTER WHICH THE PATIENTS DEVELOPED IATROGENIC GRANULOMATOUS INFLAMMATORY REACTIONS TO HYDROPHILIC COATING MATERIAL EMBOLIZATION. THE THREE CASES WILL BE REPORTED UNDER PATIENT IDENTIFIERS (B)(6). ANOTHER MANUFACTURER¿S CATHETERS WERE ALSO USED DURING THE PROCEDURES, AS WELL AS UNSPECIFIED STENTS. A FEW WEEKS AFTER THE PROCEDURES, THE PATIENTS DEVELOPED NEUROLOGICAL DEFICITS, SECONDARY TO MULTIPLE TINY NODULES OF INFLAMMATION IN THE AREA OF THE BRAIN SUPPLIED BY THE ARTERIES INVOLVED IN THE PROCEDURES. REPORTEDLY, THE USER BELIEVES THAT SOME OF THE COATING MATERIAL OF ANY OF THE DEVICES USED DURING THE PROCEDURES MAY HAVE DETACHED AND EMBOLIZED DISTALLY, CAUSING INFLAMMATION IN SENSITIVE PATIENTS. PER THE REPORTER, THE COATING OF THE UNKNOWN STENT IS NOT BELIEVED TO BE THE CULPRIT IN ALL THREE CASES, AS ONE CASE ALSO INVOLVED TERRITORY OF BRANCHES PROXIMAL TO THE LOCATION OF THE STENT. THE USER SUSPECTS THAT THE EMBOLIZED PARTICLES MAY HAVE ORIGINATED FROM THE SHEATH OR OTHER MANUFACTURER¿S GUIDING CATHETERS, WHICH ARE SUBJECT TO FRICTION DURING STENT DEPLOYMENT. THE PATIENTS WERE HOSPITALIZED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 31OCT2025. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY TO TARGET A TORTUOUS LEFT POSTERIOR CEREBRAL ARTERY. RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF THE SHEATH, NOR DURING INSERTION OR REMOVAL OF ANY DEVICE THROUGH THE SHEATH. SEPARATION OF HYDROPHILIC COATING WAS NOT VISIBLE. ANOTHER MANUFACTURER¿S STENT WAS USED DURING THE PROCEDURE. NEUROLOGICAL DEFICITS WERE NOT PRESENT BEFORE THE PROCEDURE. THE PATIENT DEVELOPED DIPLOPIA (DOUBLE VISION) AFTER THE PROCEDURE. THE NEUROLOGICAL DEFICITS HAVE RESOLVED, AND THE PATIENT REPORTEDLY HAS NOT EXPERIENCED ANY PERMANENT IMPAIRMENT OR PERMANENT DAMAGE DUE TO THE EVENT; HOWEVER, THE PATIENT REQUIRES CHRONIC IMMUNOSUPPRESSANTS, AS THE SYMPTOMS RECURRED AFTER CEASING THE INITIAL COURSE OF STEROIDS.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51445 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G13539 14395407 00827002135390

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H MEDTRONIC PHENOM 27 CATHETER.| MEDTRONIC PHENOM 27 CATHETER.| MEDTRONIC PHENOM PLUS CATHETER.| MEDTRONIC PHENOM PLUS OR MEDTRONIC REACT CATHETER.| MEDTRONIC PIPELINE PED2.