BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDY OTW VASCULAR RETRIEVER

    MDR report key: 9474883 · Received December 16, 2019

    Report

    Report Number
    1820334-2019-03120
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    December 2, 2019
    Report Date
    August 14, 2020
    Manufacturer
    COOK INC
    Product Code
    MMX
    UDI-DI
    00827002518360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: SECTION C H6- ADDITIONAL METHOD CODE: ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY (4112) INVESTIGATION - EVALUATION. (B)(6) CANADA) INFORMED COOK ON 02DEC2019 OF AN INCIDENT INVOLVING AN INDY OTW VASCULAR RETRIEVER, RPN: INDY-8.0-35-100-40 FROM LOT: 9903854. IT WAS REPORTED THAT THE PROXIMAL PORTION OF THE SNARE DETACHED FROM THE SHAFT INSIDE THE PATIENT. THE 68-YEAR-OLD MALE PATIENT HAD BEEN DIAGNOSED WITH A THORACO-ABDOMINAL ANEURYSM AND UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) PROCEDURE ON (B)(6) 2019. A CUSTOM-MADE GRAFT WITH TWO FENESTRATIONS (NO MANUFACTURER PROVIDED) AND TWO BRANCHING GRAFTS (NO MANUFACTURER PROVIDED) WERE IMPLANTED IN THE PROCEDURE. A THROUGH-AND-THROUGH TECHNIQUE FROM THE AXILLARY ARTERY WAS BEING PERFORMED USING A TERUMO RADIFOCUS GLIDEWIRE (GR1807, LOT: 181108) AND A COOK INDY OTW VASCULAR RETRIEVER (RPN: INDY-8.0-35-100-40, LOT: 9903854) FROM THE LEFT GROIN. ONCE THE TERUMO GLIDEWIRE WAS CAUGHT IN THE SNARE, IT WAS WITHDRAWN WITH THE COOK INDY OTW VASCULAR RETRIEVER IN THE CLOSED POSITION TO REMOVE BOTH DEVICES OUT OF THE GROIN. IN THE FEMORAL ARTERY, THE PROXIMAL PORTION OF THE COOK INDY OTW VASCULAR RETRIEVER DETACHED FROM ITS SHAFT. THE DETACHED SECTION REMAINED IN THE PATIENT'S FEMORAL ARTERY AND WAS REMOVED VIA OPEN RETRIEVAL. VASCULAR SURGEON, RICARDO RUZ, INDICATED THAT HE WAS THE OPERATOR OF THE DEVICE WHEN IT BROKE INSIDE THE PATIENT. HE STATED THAT THERE WAS RESISTANCE PRIOR TO THE BREAK AND THAT THE ¿0.018 WIRE THAT WAS SNARED WAS MAYBE TOO STIFF TO ENTER THE SHEATH AS THE SNARE BROKE OFF RIGHT AT THE TIP OF THE SHEATH¿. DR. STEPHANE ELKOURI, VASCULAR SURGEON PERFORMED AN OPEN RETRIEVAL OF THE SEPARATED PORTION OF THE DEVICE AND THEN PATCHED THE ARTERY. THE PATIENT OUTCOME WAS REPORTED AS BEING ¿GOOD.¿ A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WAS CONDUCTED DURING THE INVESTIGATION. ONE USED INDY SNARE DEVICE WAS RETURNED TO COOK FOR EVALUATION. UPON VISUAL INSPECTION, THE DISTAL SNARE BASKET WAS NOTED TO BE SEPARATED AT THE PROXIMAL END OF THE SUTURE WRAPS, WHICH WERE UNRAVELED WITHIN THAT AREA. THE SNARE LOOPS WERE OBSERVED TO BE TANGLED WITH BIOMATTER. NO DIFFICULTY WAS EXPERIENCED ADVANCING OR RETRACTING THE LIGHT BLUE CATHETER THROUGH THE SHEATH. A KINK IN THE SHEATH WAS FOUND WHERE THE DISTAL END OF THE CATHETER HANDLE SITS. THE DISTAL END OF THE SHEATH WAS DAMAGED AND OUT OF ROUND. TWO KINKS WERE NOTED ON THE CATHETER NEAR THE DISTAL END OF THE CATHETER HANDLE. THE CATHETER WAS ALSO NOTED TO BE DEFORMED AND FLATTENED FROM THE END OF THE CATHETER HANDLE TO THE SEPARATION POINT. DAMAGE TO THE DISTAL END OF THE SHEATH MAY INDICATE THAT FORCEFUL RETRACTION WAS USED ON THE SNARED OBJECT AGAINST THE SHEATH. THIS IS ALSO SUPPORTED BY INNER CATHETER DEFORMATION AND SMALL OUTER DIAMETER PROXIMAL TO THE SEPARATION POINT. THE LENGTH AND OUTER DIAMETER OF THE SUTURE WRAPS MEASURED OUT OF SPECIFICATION DUE TO INNER CATHETER ELONGATION AND UNRAVELING AT THE SEPARATION POINT. OTHER COMPONENTS OF THE DEVICE WERE MEASURED WITHIN TOLERANCE. THOUGH THE DEVICE'S INNER CATHETER ASSEMBLY IS MANUFACTURED BY AN EXTERNAL SUPPLIER, NO SUPPLIER INVESTIGATION WAS NECESSARY AS THE COMPONENT WAS MEASURED TO SPECIFICATION. COOK HAS CONCLUDED THAT THE PRODUCT WAS MANUFACTURED TO CURRENT SPECIFICATIONS. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE (DHF) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR IT INTENDED USE. A REVIEW OF THE DEVICE HISTORY RECORDS(DHRS) FOR THE REPORTED COMPLAINT DEVICE LOT (9903854) AND THE RELATED SUB-ASSEMBLY LOTS REVEALED NO NON-CONFORMANCES. A DATABASE SEARCH FOUND NO OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: ¿ PRECAUTIONS - "VISUALLY INSPECT THE PRODUCT BEFORE USE TO ENSURE IT IS UNDAMAGED." ¿ INSTRUCTIONS FOR USE - "4. INSERT THE RETRIEVER OVER-THE-WIRE THROUGH AN IN SITU GUIDING CATHETER OR INTRODUCER SHEATH AND ADVANCE IT TO THE DESIRED POSITION. - 6. POSITION THE RETRIEVER SO THAT THE FOREIGN BODY IS CAUGHT WITHIN THE SNARE. WHILE MAINTAINING THE SNARE POSITION, SLIDE THE FLEXOR SHEATH FORWARD TO CAPTURE THE FOREIGN BODY. - 7. TIGHTEN TUOHY-BORST TO MAINTAIN TENSION ON THE CATHETER CONTROLLING THE FOREIGN BODY, WITHDRAW THE RETRIEVER TO A PERIPHERAL LOCATION AND RETRIEVE THE FOREIGN BODY." BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE HAS BEEN TRACED TO THE USER'S FAILURE TO FOLLOW INSTRUCTIONS. BASED ON THE INFORMATION PROVIDED, THE SNARED GLIDEWIRE WAS LIKELY ATTEMPTED TO BE REMOVED THROUGH THE FLEXOR SHEATH OF THE DEVICE. ONCE THE INTENDED OBJECT IS SNARED, THE PRODUCT IFU INSTRUCTS TO MAINTAIN TENSION BY TIGHTENING THE TUOHY-BORST. THEN AFTER THE INNER CATHETER IS SECURED, WITHDRAW THE ENTIRE DEVICE TO A PERIPHERAL LOCATION AND RETRIEVE THE SNARED OBJECT. THE FORCE USED DURING THE ATTEMPT TO WITHDRAW THE SNARED OBJECT THROUGH THE SHEATH LIKELY EXCEEDED THE TENSILE STRENGTH OF THE INNER CATHETER, RESULTING IN THE SEPARATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR THE EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: TERUMO .018 GLIDEWIRE GUDIEWIRE. (B)(6). PMA/510(K) #: K160593. (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL PORTION OF AN INDY OTW VASCULAR RETRIEVER DETACHED FROM THE SHAFT WHILE IT WAS INSIDE THE PATIENT. A THORACO-ABDOMINAL PROCEDURE WAS BEING PERFORMED ON A (B)(6) YEAR OLD MALE WITH A CUSTOM MADE GRAFT WITH 2 FENESTRATION AND 2 BRANCHES. A "THROUGH-AND-THROUGH" FROM THE AXILLARY ARTERY WAS BEING PERFORMED WITH A GUIDEWIRE AND THE INDY SNARE FROM THE LEFT GROIN. ONCE THE GUIDEWIRE WAS CAUGHT IN THE SNARE, IT WAS WITHDRAWN IN THE CLOSED POSITION IN ORDER TO GET THE DEVICES OUT OF THE GROIN. THIS IS WHEN THE PROXIMAL PORTION OF THE SNARE DETACHED FROM ITS SHAFT AND WAS LYING IN THE PATIENT'S LEFT FEMORAL ARTERY. THE SURGEON THEN HAD TO PERFORM AN OPEN RETRIEVAL OF THE DEVICE AND AN ARTERY PATCH REPAIR. IT WAS REPORTED THE OUTCOME IS "GOOD". THE PHYSICIAN STATED THAT THERE WAS RESISTANCE PRIOR TO THE BREAK. IT SEEMS LIKE THE WIRE THAT WAS SNARED MIGHT HAVE BEEN TOO STIFF TO ENTER THE SHEATH, AS THE SNARE BROKE OFF RIGHT AT THE TIP OF THE SHEATH. THERE WAS NO TORTUOSITY IN THE FEMORAL ARTERY WHERE THE DEVICE SEPARATED. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269632 INDY OTW VASCULAR RETRIEVER MMX DEVICE, PERCUTANEOUS RETRIEVAL MMX COOK INC N/A 9903854 00827002518360

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention