BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH

    MDR report key: 20184749 · Received September 10, 2024

    Report

    Report Number
    2522007-2024-00031
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 23, 2024
    Report Date
    November 12, 2024
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    00827002250833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN. E3 - OCCUPATION: DOCTOR. G5 ¿ PMA/510(K): K141148. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS UNKNOWN, HOWEVER THE DEVICE WAS RETURNED, AND THE LOT WAS KNOWN. G5 ¿ PMA/510(K): K141148. ONE LR-TSS-11.0 WAS RETURNED ALONG WITH A SEPARATED STAINLESS-STEEL TIP. (IT WAS TWO SEPARATE PARTS.) THE COMPLAINT / EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "A STAINLESS STEEL DISTAL TIP WAS COME OFF." THE QUALITY ASSURANCE DEPARTMENT AND ENGINEERING PERFORMED AN INVESTIGATION AND EVALUATION ON THE RETURNED DEVICE. THE SHEATH AND TIP WERE INVESTIGATED UNDER INCREASED MAGNIFICATION USING A MICROSCOPE/COMPUTER INSPECTION STATION. THEY WERE VISUALLY INSPECTED. VISUALLY THE DEVICE HAD BLOOD PRESENT THROUGHOUT THE DEVICE INCLUDING SMALL CHUNKS WITHIN THE SHEATH. THE DEVICE SHOWED THERE WAS ADHESIVE PRESENT ON THE STAINLESS-STEEL TIP. THE SHEATH WAS INVESTIGATED INTERNALLY AND CUT OPEN BY THE ENGINEERS, WHICH IT WAS NOTED THAT ON THE INNER SIDE OF THE SHEATH SHOWED SOME SORT OF GOUGING APPROXIMATELY 3MM OF THE INNER SHEATH. IT IS UNCERTAIN AT THIS TIME THE CAUSE, BUT THE CUSTOMER'S COMPLAINT WAS INDEED CONFIRMED THAT THE STAINLESS-STEEL TIP DID COME OFF AND SHOWING THE DEVICE WAS USED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROL RECORDS AND THERE ARE NO SIGNS TO INDICATE THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. THIS COMPLAINT IS ASSOCIATED WITH INTERNAL INVESTIGATION REQUEST, (B)(4). THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    MEDICAL HISTORY: UNKNOWN. INFECTIOUS DISEASE: YES, BUT DETAILS UNKNOWN. APPROACH VIA LEFT SUBCLAVIAN VEIN, PLANNING TO USE IT FOR RV LEAD. WHEN LR-TSS-11.0 WAS SET ON EVOLUTION11FR AND USED IN FRONT OF SVC TO DETACH THE ADHESION OF RA LEAD, THE DETACHMENT DID NOT PROCEED. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE EVOLUTION11FR AND THE PRODUCT IN QUESTION, THE STAINLESS STEEL TIP OF THE PRODUCT CAME OFF. SINCE THERE WAS A POSSIBILITY THAT THE STAINLESS STEEL TIP MIGHT FLY TO OTHER PARTS OF THE BODY IF THE LR-TSS-11.0 WAS REMOVED AS IT WAS, A SHEATH FOR MEDTRONIC MICRA WAS INSERTED THROUGH THE FEMORAL VEIN AND THE TIP OF THE RA LEAD WAS RETRACTED. THE EVOLUTION 11FR AND LR-TSS-11.0 WERE ALSO INSERTED INTO THE MICRA SHEATH TO PREVENT THE STAINLESS STEEL TIP FROM FLYING OFF, AND A GUIDE WIRE WAS PASSED THROUGH THE EVOLUTION 11FR AND A VALVE WAS INSERTED THROUGH THE FEMORAL VEIN. THE BALLOON WAS PASSED THOUGH THE STAINLESS STEEL TIP AND INFLATED, THE STAINLESS STEEL TIP WAS FIXED WITH THE BALLOON, AND THEN REMOVED FROM THE FEMORAL VEIN. AFTER THE ADDITIONAL PROCEDURE, THE PATIENT WAS NO PROBLEMS. PHYSICIAN'S COMMENT OBTAINED BY A SALES REP FROM A DISTRIBUTOR : THE TIP WAS REMOVED WITHOUT THE APPEARANCE OF EXERTING MUCH FORCE. THIS WAS THE FIRST TIME THIS HAD HAPPENED.

    Description of Event or Problem · 0

    MEDICAL HISTORY: UNKNOWN. INFECTIOUS DISEASE: YES, BUT DETAILS UNKNOWN. APPROACH VIA LEFT SUBCLAVIAN VEIN, PLANNING TO USE IT FOR RV LEAD. WHEN LR-TSS-11.0 WAS SET ON EVOLUTION 11FR AND USED IN FRONT OF SVC TO DETACH THE ADHESION OF RA LEAD, THE DETACHMENT DID NOT PROCEED. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE EVOLUTION 11FR AND THE PRODUCT IN QUESTION, THE STAINLESS-STEEL TIP OF THE PRODUCT CAME OFF. SINCE THERE WAS A POSSIBILITY THAT THE STAINLESS-STEEL TIP MIGHT FLY TO OTHER PARTS OF THE BODY IF THE LR-TSS-11.0 WAS REMOVED AS IT WAS, A SHEATH FOR MEDTRONIC MICRA WAS INSERTED THROUGH THE FEMORAL VEIN AND THE TIP OF THE RA LEAD WAS RETRACTED. THE EVOLUTION 11FR AND LR-TSS-11.0 WERE ALSO INSERTED INTO THE MICRA SHEATH TO PREVENT THE STAINLESS-STEEL TIP FROM FLYING OFF, AND A GUIDE WIRE WAS PASSED THROUGH THE EVOLUTION 11FR AND A VALVE WAS INSERTED THROUGH THE FEMORAL VEIN. THE BALLOON WAS PASSED THOUGH THE STAINLESS-STEEL TIP AND INFLATED, THE STAINLESS-STEEL TIP WAS FIXED WITH THE BALLOON, AND THEN REMOVED FROM THE FEMORAL VEIN. AFTER THE ADDITIONAL PROCEDURE, THE PATIENT WAS NO PROBLEMS. PHYSICIAN'S COMMENT OBTAINED BY A SALES REP FROM A DISTRIBUTOR: THE TIP WAS REMOVED WITHOUT THE APPEARANCE OF EXERTING MUCH FORCE. THIS WAS THE FIRST TIME THIS HAD HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295198 LEAD EXTRACTION STEADYSHEATH¿ EVOLUTION® TISSUE STABILIZATION SHEATH DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC G25083 N202549 00827002250833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention LR-EVN-11.0RL.