MAUDE Adverse Event Report: ETHICON INC. VISTASEAL DUAL APPLICATOR; FIBRIN SEALANT PREPARATION DEVICE

Catalog Number	VSTAS1
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H6.Component code: g07002 - device not returned.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: 1.Is the user a new user to vistaseal? if not, how many times have they used vistaseal prior to this event? no, they converted to vistaseal in march, have had no issues prior.2.How many times have they applied the laparoscopic tip? more than 20.3.Was a sales representative present during the case when the issue was experienced? no.4.Was any leakage or product solution observed at the luer locks connection? unknown, scrub tech and circulator said the luer lock appeared to be ¿frozen/stuck¿ and would not unlock to replace open tip with lap tip.5.Were there any unexpected outcomes or complications as a result of the event? 15 minute surgery delay since new vistaseal needed to be defrosted.6.Are there pictures of the damaged device available? device available to be shipped.7.Is the device available to be returned for evaluation? if so, please provide the status of the return and any available tracking information.Yes.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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.
Event or Problem Description
It was reported that a patient underwent a urology procedure on (b)(6) 2024 and a fibrin sealant preparation device was used.The staff was unable to be able to open the lure locks to remove the tip.Another like device was used to continue with the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 4.Primary udi number, d 9.Device available for evaluation? additional information: d 4.Expiration date, d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 4.Device manufacture date, h6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H6 component code: g07002 - pending evaluation of returned device.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h 6.Type of investigation, h 6.Component code, h 6.Investigation findings, h 6.Investigation conclusions.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the vstas1 device was returned with the adapter attached and luer locks damaged was returned, in addition, the pre-filled syringe fill and an additional dual applicator with luer locks damaged.In an attempt to replicate the reported incident, the device was functionally tested to detect any functional issues.Upon evaluation of the device, it was functionally tested, and the luers move but cannot remove the spray and drip tip from the adapter.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.Additional information: lnstituto grifols, s.A upon the reception of the notified incident, it was requested additional information such as the experience of the user, the presence of any leakage observed at the connection, as well as the availability of pictures/sample of the involved device.The following additional information was received: the user is not new.No leakage was observed at the luer locks connection.The luer lock appeared to be "frozen/stuck" and would not unlock to replace open tip with lap tip.The involved device was available for evaluation, and it was returned to ethicon facilities.According to our standard procedures, it was initiated an investigation focused on the following: a.Evaluation of the returned sample at ethicon facilities: it was received from ethicon the investigation related to the returned unit.The investigation conducted by ethicon indicated the following: visual analysis of the returned sample determined that the dual applicator device was returned with damage in the luer locks.In addition, it was returned pre-filled syringes filled and an additional dual applicator with luer locks damaged.In an attempt to replicate the reported incident, the device was functionally tested (unscrew the luer locks) to detect any issue.Upon evaluation of the device, the luer locks move but cannot remove the spray and drip tip from the adapter.As part of ethicon's quality process all devices are manufactured, inspected, and released to approved specifications.According to ethicon investigation no conclusion could be reached as to what may have caused the reported incident.B.Investigation of the dual applicator tip: considering the nature of the reported incidence, it was requested to ethicon to carry out an investigation of the batch of tips involved, as ethicon is the supplier of vistaseal dual applicator.The investigation was focused on reviewing the results of batch records for the batch of tips used.It is concluded that all the components parts utilized for the involved batch met the established specifications with no incidents related.C.Results of quality control performed at ig facilities: institute grifols, s.A.Reviewed the results of the quality controls performed to the incoming materials (tips) involved in the notification.A review of the results related to the luer lock functionality performed to incoming tips kitted with the involved batch, a04j112201, was performed.The results were found correct within specifications and no deviations were detected.Based on the investigation performed and the evaluation of the returned device, it is concluded that the reported notification is not related to the quality of the product or any of the related components.No conclusion could be reached as to what may have caused the reported incident.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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.

• Brand Name: VISTASEAL DUAL APPLICATOR
• Common Device Name: FIBRIN SEALANT PREPARATION DEVICE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): TESSY PLASTICS CO. LTD; 509 ren qing road; pudong 20120 1; CH 201201
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20891488
• Report Number: 2210968-2024-13100
• Device Sequence Number: 7902571
• Product Code: MZM
• UDI-Device Identifier: 10705031462533
• UDI-Public: (01)10705031462533(17)280813(10)3401822
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: BK180287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VSTAS1
• Device Lot Number: 3401822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 01/21/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/08/2025; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown