MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No reported clinical effect reported.The clinician sutured the hole, checked the device for patency.Prolonged surgery - by an unspecified period of time medical device.Identification of a small a hole in the device.The device is composed of a main body and branches which are manufactured from different diameters of the same material.Analysis of production records - a review of qc and manufacturing records was performed with attention to porosity testing results.Review showed batch was manufactured to design specification and all porosity testing fell within acceptance criteria.Type of investigation: trend analysis - a 5-year review of similar complaints was performed for all gelsoft branded devices provided an incidence rate of (b)(4).No further complaints were received from devices from same batch.Communication/interviews - vascutek ltd.Has requested further information from site regarding the circumstances of the event relative to how the graft was used/handled and the clinicians opinion on graft performance.Device not accessible for testing - device remains implanted and was not returned for investigation.No device problem found - no issue was found with the review of batch manufacture or testing prior to release.Conclusion not yet available - vascutek ltd.Has requested additional information regarding the circumstances of the event from the clinician; as yet, no information has been provided.If/when this information has been received and evaluated, follow up reporting will be supplied.
Event or Problem Description
Customer reported detecting a small hole in the graft after it was sutured in place.Hole was sutured using prolene, the graft was deemed patent & the procedure was completed.No patient harm or injury was reported.
Additional Manufacturer Narrative
Manufacturers narrative: investigation conclusions - 4315 - (b)(4) had requested from the reporting distributor; however, they were unable to obtain any supplemental information.As no information will be supplied, no further investigation is possible.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.Vascutek ltd considers this case as closed.
Event or Problem Description
Customer reported detecting a small hole in the graft after it was sutured in place.Hole was sutured using prolene, the graft was deemed patent & the procedure was completed.No patient harm or injury was reported.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11234984
• Report Number: 9612515-2021-00006
• Device Sequence Number: 4140988
• Product Code: DSY
• UDI-Device Identifier: 05037881115511
• UDI-Public: 05037881115511
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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 Expiration Date: 12/31/2021
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631407P-G
• Device Lot Number: 17647300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention