MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT BIFURCATE

Model Number	GELSOFT BIFURCATE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative: (b)(4).Trend analysis - review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of (b)(4).Communication/interviews - information has ben requested from the clinician regarding the procedure.Analysis of production records - a review of the retained qc and manufacturing records for this batch (with attention to all in process and base material porosity testing) confirmed that the batch was manufactured to its design specification.Device not returned - device remains implanted and will not be returned for further investigation.Investigation findings : no device problem found - no issue was found with the manufacturing of the batch (based on the review of the retained production records).Cause traced to user not following instructions.Additional information received from the distributor via the clinician confirmed that 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.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
Tc (b)(4) reported that during a procedure on (b)(6) 2021, a gelsoft plus bifurcate leaked from the bifurcation (approx.5ml of blood leaked).The leak site was sutured, and the procedure was completed successfully without any further incident.The patient did not suffer any harm or injury.Also the site reported that no forceps/clamps were used on the leak site; but advised that the bifurcation area may have been "pulled", though this is unconfirmed.

• Brand Name: GELSOFT
• Common Device Name: GELSOFT BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11493580
• Report Number: 9612515-2021-00010
• Device Sequence Number: 2869951
• Product Code: MAL
• UDI-Device Identifier: 05037881115542
• UDI-Public: 05037881115542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P890045/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/16/2021

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: 09/30/2021
• Device Model Number: GELSOFT BIFURCATE
• Device Catalogue Number: 632010P-J
• Device Lot Number: 21439401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/16/2021
• 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