MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; 4 BRANCH BROKEN TWILL SEALED GRAFT

Model Number	GELWEAVE
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers narrative (b)(4).No reported significant delay to procedure, patient consequence or harm.Pinhole leak was repaired with application of bioglue and patient reported as stable post op.(b)(4).Historical data analysis:a 5-year review of previous complaints was carried out and gave an occurence rate of (b)(4) (complaints v sales) across all gelweave products.Analysis of production records: review of retained qc, manufacturing and physical testing records performed: a review of retained qc and manufacturing records showed that this batch was manufactured to specification with no issues raised.A review of the graft base material physical tests showed all testing met acceptance criteria.Base material porosity tests and finished product porosity tests were all within specification with no issues highlighted.Device not accessible for testing: device remains implanted in patient and will not be returned for testing.Review of product batch records showed no issue with the manufacture of this batch.Without the return of the product no further investigation into the root cause of this leakage 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.Now considers this complaint closed.
Event or Problem Description
Event was reported to vascutek ltd as follows: "oozing blood from needle hole".Accompanying video shows leakage from sewn area of branch root.

• Brand Name: GELWEAVE
• Common Device Name: 4 BRANCH BROKEN TWILL SEALED GRAFT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 8572596
• Report Number: 9612515-2019-00007
• Device Sequence Number: 13974883
• Product Code: DSY
• UDI-Device Identifier: 05037881106335
• UDI-Public: 05037881106335
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K162794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2019
• Report Date (Section F): 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: GELWEAVE
• Device Catalogue Number: 73261088/8-G
• Device Lot Number: 17107379
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/02/2019
• 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
• Patient Age: 42 YR