MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT BIFURCATE

Model Number GELSOFT BIFURCATE

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

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 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
• Type of Device: GELSOFT BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire, PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 11493580
• MDR Text Key: 246975088
• Report Number: 9612515-2021-00010
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 05037881115542
• UDI-Public: 05037881115542
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P890045/S1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention