| Catalog Number |
VSTAS1 |
| Medical Device Problem Codes |
Failure to Disconnect (2541); Device Stenosis (4066)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
04/14/2025
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, 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.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.What is the product code of the vistaseal kit used (vst02, vst04, vst10)? 2.What is the lot number of the vistaseal kit involved? 3.What is the lot number of the laparoscopic applicator involved (vstl45) 4.Was the plunger easy to express upon the first spray? 5.What was the thawing process used? a.Warm bath: i.Temperature: ii.For how long (in minutes)?: iii.Was the product thawed with or without blister?: b.Room temperature: i.Temperature: ii.For how long (in minutes)?: 6.Was there any observation around the plunger being depressed prior to spraying? (during setup or inadvertently pressing during handling before application) 7.Did the device clog during the first spray or after a tip change? 8.If the tip was changed before clogging, how was the tip changed? was the proper wiping technique of the threaded connector used? 9.Confirm if the device was purged of air prior to installing the dual applicator.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.
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Event or Problem Description
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It was reported that a patient underwent a gyn procedure on (b)(6) 2025 and a fibrin sealant preparation device was used.During the procedure, once the applicator was attached, the product would not dispense.The applicator was attempted to be removed, but it would not come off.Another like device was used to continue with the procedure.No adverse patient consequences were reported.Additional information was requested.
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Additional Manufacturer Narrative
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Product complaint # (b)(4).Additional information was requested, and the following was obtained: 1.What is the product code of the vistaseal kit used (vst02, vst04, vst10)? vst10 2.What is the lot number of the vistaseal kit involved? - not sure 3.What is the lot number of the laparoscopic applicator involved (vstl45) - not sure 4.Was the plunger easy to express upon the first spray? - no it wouldn¿t work 5.What was the thawing process used?- thawed it out in a room temperature bath a.Warm bath: i.Temperature: not sure ii.For how long (in minutes)?: - 5-10 minutes iii.Was the product thawed with or without blister?: with b.Room temperature: i.Temperature: ii.For how long (in minutes)?: 5-10 minutes 6.Was there any observation around the plunger being depressed prior to spraying? (during setup or inadvertently pressing during handling before application) no 7.Did the device clog during the first spray or after a tip change? before first spray 8.If the tip was changed before clogging, how was the tip changed? was the proper wiping technique of the threaded connector used? couldn¿t remove tip to change 9.Confirm if the device was purged of air prior to installing the dual applicator.Not sure 10.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.
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Additional Manufacturer Narrative
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Product complaint # (b)(4) corrected information: d 9.Device available for evaluation? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer? h 6.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.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.
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Additional Manufacturer Narrative
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Product complaint#: (b)(4).Corrected information: h3.Device evaluated by manufacturer? additional information: h 6.Component code, h 6.Type of investigation, 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 only the adapter from the vstas1 device was returned with damaged in the luer locks attached to the syringe holder with pre-filled syringes still with component.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 correctly and can be both tightened and loosened without issues observed and no clogged was observed as each syringe dispatched the biologics individually as intended.The device was fully functional according to the manufacturing requirements.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 could not be confirmed.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.Per instructions for use: ¿loosen the luer locks to remove the spray and drip tip from the adapter, attach the vistaseal laparoscopic dual applicator to the adapter by tightening the luer lock¿.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Additional information was requested, and the following was obtained: lnstituto grifols s.A.(ig) upon the reception of the notified incident, it was requested additional information such as the batch number of the affected unit, details of the thawing and administration procedures followed, the appearance of the product after thawing as well as the availability of pictures.The following information was received: the plunger would not work.The thawing process used was room temperature bath during 5-10 minutes in the blister.The device was clogged before the first spray and the tip could not been removed.Considering the nature of the incidence reported, ig initiated an investigation focused on: a.Evaluation of the returned device at ethicon facilities: the investigation conducted by ethicon indicated the following.The device was returned with damaged in the luer locks attached to the syringe holder pre-filled syringes still with component.The device was tested to detect any functional issues, the luers move correctly and can be both tightened and loosened without issues observed and no clogged was observed as each syringe dispatched the biologics individually as intended.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.Evaluation of the pictures provided by ethicon facilities: regarding the connection issue with the dual applicator, according to this picture (figure 1) the returned tip shows signs of damage, and it could be noticed marks on the grey luer locks.Additionally, it could be observed that the appearance of the fibrinogen component was white.Based in our experience with this product, this type of appearance in fibrinogen is comparable to the appearance of fibrinogen denaturalized for high temperatures.In the picture below, it is compared the appearance of fibrinogen and thrombin components when the product has been thawed at 48°c during 5 minutes, where the fibrinogen is denaturalized (figure 2) and the appearance of the product involved in the notification (figure 3).Due to the absence of batch number it has not been possible to carry out a proper investigation in ig and it has not been possible to find a root cause for this defect.Considering the results of the investigation performed by ethicon regarding the returned unit it can be concluded that the reported notification is not related to the quality of the product or any of the related components.Based on the pictures received, the luer locks shows damaged and the fibrinogen appearance shows as denaturalized.We would like to remark the importance of following the leaflet instructions and highlight the following indication: do not use any external element or tool to dissemble the tips and unscrew the locks manually.Additionally, to the importance to closely follow the instructions in the leaflet regarding the thawing process.According to the leaflet, for the 10 ml package size, the product should be thawed with blister at room temperature (20 °c - 25 °c [68 °f - 77 °f]) for approximately 90 minutes.If the product is thawed using sterile water bath procedure, the temperature must not be higher than 37°c (99 °f).At this temperature, the time needed is approximately 5 minutes.The product must not be left at this temperature for longer than 10 minutes.After thawing, the solutions must be clear to slightly opalescent and colorless to pale yellow; the solutions must not be cloudy or have deposits.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.
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