MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Model Number GELSOFT PLUS BIFURCATE

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided.(b)(4) - there was no health effect on patient resulting from this event.(b)(4) - there were no consequences or impact on patient health resulting from this event.(b)(4) - clinician reported that blood was leaking form a hole on the branch root of the graft.(b)(4) - the graft is manufactured from a continuous knitted tube of material and as such does not contain any sub-assembly or additional component parts.Type of investigation: a 5-year review of previous complaints related to hole/pinhole leakage of gelsoft range of grafts was performed and showed an occurrence rate of (b)(4) (complaints v sales).There were no additional complaints received for this batch of grafts and no increasing trend was noted.Qc and manufacturing records were retrieved and reviewed and show batch was manufactured to design specification- all porosity tests performed on base material and in process grafts were well within acceptance criteria and no issues were noted.Vascutek requested further information from site on procedure and treatment of patient that may have affected device performance.- additional information was received however for most questions posed no useful information was received - only patient current condition was updates where no health damage was reported.No issue was found with the manufacture or testing of batch - no device was returned for investigation as remains implanted in patient.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

Event was reported to vascutek ltd as follows: blood leakage: blood leakage was identified from branch root part of the gelsoft plus bifurcate when the device was implanted.The physician sutured the leak part, hemostasis was successfully achieved and the procedure was successfully completed.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS 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: 11200098
• MDR Text Key: 256678113
• Report Number: 9612515-2021-00005
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115542
• UDI-Public: 05037881115542
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990503
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 632010P
• Device Lot Number: 18023388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2019
• 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