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

Model Number	GELSOFT PLUS BIFURCATE
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided.(b)(4) - there was no health effect on patient resulting from this event.(b)(4) - there were no consequences or impact on patient health resulting from this event.(b)(4) - clinician reported that blood was leaking form a hole on the branch root of the graft.(b)(4) - the graft is manufactured from a continuous knitted tube of material and as such does not contain any sub-assembly or additional component parts.Type of investigation: a 5-year review of previous complaints related to hole/pinhole leakage of gelsoft range of grafts was performed and showed an occurrence rate of (b)(4) (complaints v sales).There were no additional complaints received for this batch of grafts and no increasing trend was noted.Qc and manufacturing records were retrieved and reviewed and show batch was manufactured to design specification- all porosity tests performed on base material and in process grafts were well within acceptance criteria and no issues were noted.Vascutek requested further information from site on procedure and treatment of patient that may have affected device performance.- additional information was received however for most questions posed no useful information was received - only patient current condition was updates where no health damage was reported.No issue was found with the manufacture or testing of batch - no device was returned for investigation as remains implanted in patient.Vascutek ltd.Now considers this complaint closed.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.
Event or Problem Description
Event was reported to vascutek ltd as follows: blood leakage: blood leakage was identified from branch root part of the gelsoft plus bifurcate when the device was implanted.The physician sutured the leak part, hemostasis was successfully achieved and the procedure was successfully completed.

• 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: 11200098
• Report Number: 9612515-2021-00005
• Device Sequence Number: 19400572
• Product Code: DSY
• UDI-Device Identifier: 05037881115542
• UDI-Public: 05037881115542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

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: 11/30/2024
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 632010P
• Device Lot Number: 18023388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/20/2021
• 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