BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTASEAL DUAL APPL 3X

    MDR report key: 12046916 · Received June 22, 2021

    Report

    Report Number
    2210968-2021-05749
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    MZM
    UDI-DI
    10705031462533
    PMA / PMN Number
    BK180287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 6/28/2021. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE VSTASEAL TIP THAT EXPERIENCED THE QUALITY ISSUE COME FROM A 3 PACK OF TIPS SOLD SEPARATELY OR A VISTASEAL KIT? WAS THE VISTASEAL USED/ADMINISTERED ON THE PATIENT? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE LOT NUMBER? A4YDE00551 WAS THE TIP CHANGED BEFORE THE ISSUE OCCURRED? THIS ISSUE OCCURRED WITH THE FIRST TIP. RIGHT AWAY. THEN IT HAPPENED AFTER THE REST OF THE TIPS WERE USED. IF YES, HOW WAS THE TIP CHANGED? THE USER UNSCREWED IT, CHECKED FOR A CLOG, DIDN'T SEE ONE, BUT WIPED/PULLED AT THE TIP ANYWAYS, AND PUT THE NEW TIP ON. ARE THERE PICTURES OF THE DAMAGED DEVICE AVAILABLE? NO. IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? YES. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. DID THE VSTAS1 TIP THAT EXPERIENCED THE QUALITY ISSUE COME FROM A 3 PACK OF TIPS SOLD SEPARATELY OR A VISTASEAL KIT? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE SURGEON PUT THE SPRAY TIP ON, AND THE SOLUTION CAME OUT LIKE A "LASER," WHICH WAS NOT THE EXPECTED SPRAY PATTERN EXPECTED. THE TIP FROM A PREVIOUSLY USED DEVICE WAS PUT ON THE CURRENT DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942648 VISTASEAL DUAL APPL 3X FIBRIN SEALANT PREPARATION DEVICE MZM ETHICON INC. VSTAS1 2580898 10705031462533

    Patients

    Seq Age Sex Outcome Treatment
    1