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

Model Number	GELSOFT PLUS STRAIGHT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary of inspection/evaluation of the returned device.Evaluation of the device was performed using unaided visual inspection, aided visual inspection (utilising digital microscopy and sem analysis of the base material), porosity testing of the base material and a textiles analysis of the base material structure.The graft was received wet with no apparent blood staining present either inside or outside of the graft.As the graft had been used (implanted/explanted) and received wet (possibly washed), gelatin testing and graft whole graft porosity testing could not be completed.Unaided visual inspection of the graft identified no holes, tears or any damage to the material.Aided visual inspection of the graft also did not identify any holes, tears or damage to the material structure.Base material porosity testing confirmed that it met its expected performance specifications.Textiles analysis of the base material confirmed that the structure was consistent and undamaged.(b)(4).A review of the retained qc and manufacturing records for this batch (with attention to all in process, base material porosity testing, whole graft porosity testing) confirmed that the batch was manufactured to its design specification (b)(4).Information provided by the site was that the patient was anticoagulated normally, no unusual tension was applied to the device, although the graft was clamped, leakage was not reported from these sites; however; the site also advised that the graft was presoaked in saline for approx 30 seconds prior to use.The device was not pre-soaked in saline for approx.5 minutes prior to use which is a recommendation within the ifu (ifu states "the prosthesis must be immersed in a sterile saline solution for 5 minutes.Failure to rinse for 5 minutes could lead to the graft being more susceptible to leakage when implanted." as this recommendation was not followed this may have contributed to the leakage observed by the user.No device problem found - no structural defect was found with the graft during inspection and no issues were found during the review of the retained manufacturing records for the batch.Vascutek ltd.Considers this event as 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, if an adverse trend develops action may be taken at that time.
Event or Problem Description
A gelsoft branded graft was implanted and leaked across its length when blood was released into it following implantation.The graft was explanted and replaced with another unit.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 12057483
• Report Number: 9612515-2021-00019
• Device Sequence Number: 19834616
• Product Code: DSY
• UDI-Device Identifier: 05037881115030
• UDI-Public: 05037881115030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 06/24/2021

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: 11/30/2023
• Device Model Number: GELSOFT PLUS STRAIGHT
• Device Catalogue Number: 636007P-G
• Device Lot Number: 21540823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/24/2021
• 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
• Patient Age: 73 YR