BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    MDR report key: 9560323 · Received January 7, 2020

    Report

    Report Number
    3004939290-2020-01600
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 3, 2019
    Report Date
    February 3, 2020
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    UDI-DI
    10862028000410
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G4, G7, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. THE BALLOON OF A 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WOULD NOT DEFLATE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE PRODUCT WAS RETURNED FOR ANALYSIS. A NON-STERILE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F WAS RETURNED. PER VISUAL ANALYSIS, THE SHUTTLE CARTRIDGE WAS ENGAGED TO THE BLACK HANDLE. THE SEALANT, PROCEDURAL SHEATH AND ADVANCER TUBE WERE NOT RETURNED WITH THE DEVICE. THE BALLOON WAS FULLY DEFLATED AS RECEIVED. PER FUNCTIONAL ANALYSIS, AN ATTEMPT TO INFLATE AND DEFLATE THE BALLOON. THIS CONFIRMED THE USER'S COMPLAINT. THE BALLOON OF THE RETURNED DEVICE REMAINED PARTIALLY INFLATED WHEN THE INFLATION INDICATOR WAS FULLY RETRACTED DURING THE INVESTIGATION. PER MICROSCOPIC ANALYSIS, THE PROXIMAL END OF THE POLYIMIDE SHAFT WAS ABUTTING THE DISTAL END OF THE PLUNGER, WHICH PROHIBITED THE BALLOON FROM DEFLATING COMPLETELY. BY DESIGN, A GAP BETWEEN THE PROXIMAL END OF THE POLYIMIDE SHAFT AND THE DISTAL END OF THE PLUNGER IS NEEDED TO ALLOW FLUID/AIR TO TRAVEL FROM SYRINGE TO BALLOON. IF THE PROXIMAL END OF THE POLYIMIDE SHAFT IS PUSHED AGAINST THE PLUNGER, FLUID/AIR WILL BE TRAPPED IN THE BALLOON, RESULTING IN A BALLOON FAILURE TO DEFLATE. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT F1927702 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿DEFLATION DIFFICULTY¿ WAS CONFIRMED DURING ANALYSIS OF THE RETURNED DEVICE. PER THE PRODUCT ANALYSIS, THE EVENT WAS CAUSED BY THE PROXIMAL END OF THE POLYIMIDE SHAFT PUSHED AGAINST THE PLUNGER. THIS CAUSES FLUID/AIR BEING TRAPPED IN THE BALLOON, RESULTING IN THE BALLOON FAILING TO DEFLATE. ACCORDING TO THE MYNXGRIP IFU, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, USERS ARE INSTRUCTED TO INFLATE AND DEFLATE THE BALLOON DURING PREPARATION OF THE DEVICE. THIS ALLOWS THE USER TO VERIFY IF THE INFLATION INDICATOR AND BALLOON ARE FUNCTIONING APPROPRIATELY. THIS ISSUE APPEARS TO BE RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT. A RISK ASSESSMENT HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT F1927702 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THE BALLOON OF A 6F 7F MYNXGRIP VASCULAR CLOSURE DEVICE (VCD) WOULD NOT DEFLATE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20924 MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA MX6721 F1927702 10862028000410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK.