BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSEAL VASC. CLOS.DEV.F5

    MDR report key: 12966681 · Received December 9, 2021

    Report

    Report Number
    9616099-2021-05154
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 10, 2021
    Report Date
    February 24, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MGB
    UDI-DI
    10705032058889
    PMA / PMN Number
    P100013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS BEEN ANALYZED BUT THE FINAL, APPROVED DRAFT OF THE ENGINEERING REPORT AND ITS CONCLUSION IS NOT YET AVAILABLE DUE TO NEED FOR ADDITIONAL TESTING. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: AS REPORTED, A 5F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) "PENETRATED" THROUGH AN UNKNOWN BRITE TIP SHEATH. THERE WAS NO REPORTED PATIENT INJURY. IMAGE REVIEW DEMONSTRATES AN EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IS SEEN INSERTED THROUGH A CATHETER SHEATH INTRODUCER (CSI). THE DELIVERY SHAFT OF THE EXOSEAL IS PROTRUDING THROUGH SIDE OF THE CSI'S CANNULA. A KINK/BENT CONDITION IS NOTED TO THE CANNULA OF THE CSI AND IS LOCATED AT THE EXIT SITE OF THE EXOSEAL. THE INDICATOR WIRE OF THE EXOSEAL IS EXPOSED AND THE COWLING IS TOUCHING THE HANDLE. BLOOD IS NOTED WITHIN THE BLEED BACK INDICATOR. THERE IS A SMALL SPACE BETWEEN THE HUB OF THE CSI AND THE COWLING OF THE EXOSEAL. 170709-1 THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE EXOSEAL VASCULAR CLOSURE DEVICE 5F WAS RECEIVED INSIDE OF A CLEAR PLASTIC BAG, ALONG WITH A BRITE TIP CSI WHICH IS COMPATIBLE WITH THE ¿EXOSEAL DEVICE. PER VISUAL ANALYSIS, THE DELIVERY SHAFT WAS INSERTED INSIDE THE COMPATIBLE BRITE TIP CSI PERFORATING THE SHEATH AT APPROXIMATELY AT 3 CM FROM THE BRITE TIP CSI DISTAL TIP. THE DELIVERY SHAFT PRESENTED A KINKED CONDITION LOCATED APPROXIMATELY AT 3 CM FROM THE DISTAL TIP. THE DEPLOYMENT LEVER WAS NOT DEPRESSED. THE INDICATOR WINDOW WAS RECEIVED IN THE BLACK/WHITE POSITION. THE PLUG WAS NOT DEPLOYED. THE COWLING GUARD WAS RECEIVED LOCKED, AND THE BLEED BACK PORT WAS AT THE ORIGINAL POSITION. THE DEVICE WAS BLOOD SATURATED. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED. PER DIMENSIONAL ANALYSIS, THE OD OF THE DELIVERY SHAFT WAS MEASURED AND FOUND WITHIN SPECIFICATION. PER FUNCTIONAL ANALYSIS, THE EXOSEAL DEVICE WAS INSERTED INTO ONE APPROPRIATE AND COMPATIBLE LAB SAMPLE CSI FRENCH 5. THE RETURNED EXOSEAL DELIVERY SHAFT WAS WITHDRAWN FROM THE LAB SAMPLE CSI. DESPITE THE KINK, NO RESISTANCE OR ANOMALIES WERE OBSERVED DURING THE INSERTION/WITHDRAWAL TEST OF THE UNIT INTO THE LAB SAMPLE CSI. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17994888 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿ IMPEDED-PERFORATED SHEATH¿, ¿CATHETER SHEATH INTRODUCER KINKED/BENT¿ AND ¿CANNULA PUNCTURE/CUT - IN PATIENT¿ WERE CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICES. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO REPORTED EVENTS. ACCORDING TO THE INSTRUCTIONS FOR USE WHICH IS NOT INTENDED AS A MITIGATION OF RISK, USERS ARE INSTRUCTED NOT TO USE THE DEVICE IF THERE ARE ANY DAMAGES NOTED. THE IFU ALSO INSTRUCTS USERS TO DISCONTINUE ADVANCING THE VCD INTO THE CSI IF RESISTANCE IS MET UNTIL THE CAUSE IS DETERMINED. NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE REPORTED EVENTS COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNITS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 17994888 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, A 5F EXOSEAL VASCULAR CLOSURE DEVICE (VCD) "PENETRATED" THROUGH AN UNKNOWN BRITE TIP SHEATH. THERE WAS NO REPORTED PATIENT INJURY. IMAGE REVIEW DEMONSTRATES AN EXOSEAL VASCULAR CLOSURE DEVICE (VCD) IS SEEN INSERTED THROUGH A CATHETER SHEATH INTRODUCER (CSI). THE DELIVERY SHAFT OF THE EXOSEAL IS PROTRUDING THROUGH SIDE OF THE CSI'S CANNULA. A KINK/BENT CONDITION IS NOTED TO THE CANNULA OF THE CSI AND IS LOCATED AT THE EXIT SITE OF THE EXOSEAL. THE INDICATOR WIRE OF THE EXOSEAL IS EXPOSED AND THE COWLING IS TOUCHING THE HANDLE. BLOOD IS NOTED WITHIN THE BLEED BACK INDICATOR. THERE IS A SMALL SPACE BETWEEN THE HUB OF THE CSI AND THE COWLING OF THE EXOSEAL. PICTURE IS PROVIDED FOR ANALYSIS. THE EXOSEAL WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867341 EXOSEAL VASC. CLOS.DEV.F5 DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS CORPORATION EX500CE 17994888 10705032058889

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN BRITE TIP SHEATH