MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative.No patient information provided.Device was used as conduit for ecmo bypass, therefore, was neither implanted, or explanted.(b)(4); (b)(4).(b)(4).(b)(4).Type of investigation: historical data analysis: a review of similar events related to gel weave devices was performed and gave an occurrence rate of (b)(4).There was no indication of an increasing trend and no further complaints from any of the remaining grafts from batch have been received at this time.Communication/interviews: additional information was requested from site on procedure, and if device was pre-soaked prior to procedure as per warnings and precautions in ifu.Site informed vascutek on 23-nov that no further information on event, or device preparation was available.Analysis of production records: a review of qc and manufacturing record showed batch was manufactured to specification.All physical testing in relation to graft porosity met acceptance criteria.Investigation findings: no device problem found; no issue was found with the manufacture, and testing of the complaint batch.Conclusion: 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
Reported to vascutek ltd.As follows: patient was being placed on ecmo, and product was used to gain arterial access for bypass.Once the patient was placed on bypass it was noted that there was significant blood leakage through the graft fabric.Surgeon inspected the graft suture line to determine whether it was located there, but determined the leakage was occurring through the entire graft material.Surgeon had to insert a cannula into the graft to minimise the blood loss from the artery.Patient lost approximately 5l of blood during the procedure.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 10910331
• Report Number: 9612515-2020-00017
• Device Sequence Number: 19662005
• Product Code: DSY
• UDI-Device Identifier: 05037881105130
• UDI-Public: 05037881105130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2020

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: 05/31/2023
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 733008-G
• Device Lot Number: 21358017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/26/2020
• 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