MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT; GELSOFT STRAIGHT

Model Number GELSOFT STRAIGHT

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  malfunction  

Event Description

A femoral popliteal bypass has been performed using a gelsoft graft.After blood flow release, the surgeon observed a few pin hole leaks coming from the graft surface.Fibrin glue was used to stop the blood leakage.The procedure was completed without further issue.

Manufacturer Narrative

Health effect - clinical code - 4582 - no clinical signs/symptoms or conditions were reported.Health effect - impact code - 2199 - reported leakage event had no direct health consequence or impact.Medical device problem code - 2978 - material integrity problem reported.Medical device problem code - 1504 - material puncture / hole - site reported two pin holes in device.Component code - 4755 - term not applicable.Type of investigation - 4110 - trend analysis - review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of (b)(4).Type of investigation - 4111 - communication/interviews - information has ben requested from the clinician regarding the procedure.Type of investigation - 3331 - 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.Type of investigation - 4114 - device not returned - device remains implanted and will not be returned for further investigation.Investigation findings - 213 - no device problem found - no issue was found with the manufacturing of the batch (based on the review of the retained production records).Investigation conclusions - 11 - investigation ongoing (additional information has been requested to aid the investigation).

Event Description

A femoral popliteal bypass has been performed using a gelsoft graft.After blood flow release, the surgeon observed a few pin hole leaks coming from the graft surface.Fibrin glue was used to stop the blood leakage.The procedure was completed without further issue.

Manufacturer Narrative

Investigation conclusion code: 18 - 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.

• Brand Name: GELSOFT
• Type of Device: GELSOFT STRAIGHT
• 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: 10565235
• MDR Text Key: 208645799
• Report Number: 9612515-2020-00011
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P890045/S1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: GELSOFT STRAIGHT
• Device Catalogue Number: 634006-G
• Device Lot Number: 17827782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other