MAUDE Adverse Event Report: VASCUTEK LTD.; GELSOFT PLUS

Catalog Number 633010P-G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

As per reporter's narrative: graft leakage during the procedure, no information regarding patient preconditions.No injury to patient.Manufacturer's understanding: no information if device related, patient related or procedure related.Potential failure mode - leakage other.

Manufacturer Narrative

Manufacturers narrative h6 clinical code: 4582 no heath damage to patient.Impact code: 2199 no health damage to patient.Medical device problem code: 2993 adverse event with without identified device or use problem - leakage was noted and reported as related to the device andprocedure however graft is not being returned and was used off label for cannulation.Component code: 4755 no sub-assemblies or component parts.Type of investigation: 4109 historical data analysis: batch review performed which showed no issues 4110 trend analysis: a 5-year review of similar complaints (leakage other ) gave an occurrence rate of 0.006%.3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device 4114 device not returned: used for cannulation.4117 device not accessible for testing: used for cannulation.

Manufacturer Narrative

Manufacturers narrative h6 clinical code.4582 no heath damage to patient.Impact code.2199 no health damage to patient.Medical device problem code.2993 adverse event with without identified device or use problem - leakage was noted and reported as related to the device andprocedure however graft is not being returned and was used off label for cannulation.Component code.4755 no sub-assemblies or component parts.Type of investigation.4109 historical data analysis: batch review performed which showed no issues 4110 trend analysis: a 5-year review of similar complaints (leakage >> other ) gave an occurrence rate of (b)(4).3331 analysis of production records: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device.10 - analysis of returned device.Investigation findings.213- no device problem found during analysis of returned graft.Investigation conclusion.61 - unintended use error - analysis of the returned graft was carried out , no issues could be found with the device on further investigation.However, the graft had been stretched over a cannula which had a larger diameter than the graft itself.Gelsoft plus, like all knitted grafts has a more open textile structure.This means that when it is stretched these open areas can expand to such a point that it can cause leakage.It would appear that is what has happened in this instance, as the leakage occurred at the area of the cannula.It was also indicated thet the graft was implanted , however when further information was received and reviewed the graft was used for cannulation and was not implanted.Corrected data d9 and h3 - graft was returned to manufacturer on 02 oct 23 for eveluation.H6 type of invetigation.10 - analysis of returned device.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

As per reporter's narrative: graft leakage during the procedure, no information regarding patient preconditions.No injury to patient manufacturer's understanding: no information if device related, patient related or procedure related.Potential failure mode - leakage > other.This report is being submitted as follow up #1 for mfg report #9612515-2023-00017 to provide event closure information for comp (b)(4).

• Type of Device: GELSOFT PLUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 17698727
• MDR Text Key: 322834737
• Report Number: 9612515-2023-00017
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 633010P-G
• Device Lot Number: 25107220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male