MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT

Model Number 733008

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Event was reported as follows: graft soaked in normal saline for 3 mins prior to removal and used for femoral artery anastomosis for cardiopulmonary bypass cannulation.Blood constantly leaking through permeable gelweave graft.The patient was profusely bleeding out of the femoral artery for the duration of the case.The result was haemolysis, constant blood loss and interruption to the surgical procedure.Patient was undergoing coronary bypass and aortic valve replacement.Estimated blood loss >250ml.

Manufacturer Narrative

(b)(4).Type of investigation: historical data analysis - a five-year review of similar reported events of graft leakage relating to gelweave branded grafts was completed, an occurrence rate of (b)(4) was confirmed.No similar events have been reported from the remainder of the batch (10 grafts manufactured in total).Trend analysis - no negative trend was identified.Communication/interviews - further information / biopsy results have been.Requested analysis if production records - quality, manufacturing and physical test records of the base material were retrieved and eviewed and show that the batch was manufactured to design specification and all tests met acceptance criteria.Specific emphasis was directed toward the porosity test results which indicate that the units passed - highest -03ml/min - lowest 01ml/min - max permitted 26ml/min.Investigation findings: results pending completion of the investigation.

Manufacturer Narrative

Type of investigation: 10 - testing of actual device/suspected device.4116 - incomplete device returned.2 sections of the graft returned.First section measured to 70mm and second section measured to 90mm in length.Full lengtht of the graft supplied to the customer was 300mm.Textile analysis did not identify any damage to the graft sections returned neither structurally nor cosmetically.The sample was consistent with an 8mm gelweave graft.Permeability test of the base fabric (2 samples tested) was within specification (=<515ml/min) with following results 132ml/min and 148lm/min.Investigation finding: 213 - no device problem found.Inspection and evaluation of the physical properties of the graft did not identify any holes, tears or cuts in the structure of the graft that could have contributed to the reported graft leakage.Investigation conclusion: 67 - no problem detected.4315 - cause not established.As no issues were identified during returned graft section evaluation and manufacturing records review, the root cause of the observed leakage could not be determined.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.Vascutek ltd considers this case closed.

Event Description

Event was reported as follows: graft soaked in normal saline for 3 mins prior to removal and used for femoral artery anastomosis for cardiopulmonary bypass cannulation.Blood constantly leaking through permeable gelweave graft.The patient was profusely bleeding out of the femoral artery for the duration of the case.The result was haemolysis, constant blood loss and interruption to the surgical procedure.Patient was undergoing coronary bypass and aortic valve replacement.Estimated blood loss >250ml.This report will provide returned sample evaluation information related to the initial report 9612515-2022-00007.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE 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: 14673661
• MDR Text Key: 303240086
• Report Number: 9612515-2022-00007
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105130
• UDI-Public: 05037881105130
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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
• Device Operator: Health Professional
• Device Model Number: 733008
• Device Catalogue Number: 733008-G
• Device Lot Number: 221111016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2021
• 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