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

Model Number	GELWEAVE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative.No patient information other than 'male' provided.No patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.No additional harm or consequence for patient reported no apparent harm occurred in relation to the adverse event.Medical device: it was reported that pin hole leakage was observed during procedure.No patient involvement or, no observable clinical symptoms or a change in symptoms is identified in the patient.There was no reported harm or consequence for the patient.Historical data analysis.A review of similar events related to gelweave 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.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 (b)(4) that device was not pre-soaked prior to procedure 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: as the device was not returned for investigation and from the information received, (b)(4) could not determine a root cause for this event.It is unknown if the fact that the device was not pre-soaked had any effect therefore on the performance of the device.(b)(4).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: dissection case, total 7 hour 30 min, acc 1 hour 50 min almost end of surgery, there was pin hole bleeding on area of graft which was not touched or clamped.Surgery has been done well.Patients has no problem.After the bleeding out, surgeon sutured point of the bleeding.

• 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: 10974335
• Report Number: 9612515-2020-00019
• Device Sequence Number: 4282402
• Product Code: DSY
• UDI-Device Identifier: 05037881105758
• UDI-Public: 05037881105758
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K952293
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 08/31/2022
• Device Model Number: GELWEAVE
• Device Catalogue Number: 734030-G
• Device Lot Number: 17907241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/09/2020
• 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