MAUDE Adverse Event Report: ROYAL MELBOURNE HOSPITAL GELSOFT PLUS; GELSOFT PLUS STRAIGHT

Model Number GELSOFT PLUS STRAIGHT

Device Problem Material Integrity Problem (2978)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: a 105mm section of the 300mm graft was returned.The diameter was confirmed as 6mmwhich is consistent with the reported graft catalogue no.Blood staining was present throughout all surfaces and was received in a wet condition therefore no gelatin testing was possible as it would have hydrolysed between saline immersion, blood passing through the graft and transport to vascutek ltd.Initial visual inspection of the sample identified no visible damage (e.G.Cuts tears or holes).The graft was cut into three sections for additional testing (sem: scanning electron microscopy, textiles analysis and porosity testing of the fabric).Sem analysis identified no damage to the structure of the fabric, the knit was consistent and tightly bundled.Porosity testing confirmed that it passed the test textiles analysis confirmed that the knit was tightly bundled together and was uniform/consistent.Do damage was detected.Health effect: clinical code: (b)(4): occlusion was identified after the clinician compressed the graft to stop the leak, which led to the graft being explanted and replaced.Health effect: impact code: (b)(4): surgical intervention was required to explant the occluded device.Health effect: impact code: (b)(4); additional surgery was required to implant the replacement device.Health effect: impact code: (b)(4): the occluded device was explanted.Health effect: impact code: (b)(4): additional surgery was required to implant the replacement graft.Health effect: impact code: (b)(4): additional device was used to replace the occluded device.Medical device problem code: (b)(4): material integrity problem reported.Component code: (b)(4): term not applicable.Type of investigation: (b)(4): trend analysis: review of similar complaints of leakage for all gelsoft branded devices gave an occurrence rate of 0(b)(4).Type of investigation: (b)(4): communication/interviews: information had been requested from the site regarding the use of the device and how it was managed.The site confirmed that it was used as per ifu.Type of investigation: (b)(4): 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: (b)(4): actual device evaluated (results above).Type of investigation: (b)(4): incomplete device returned (105mm of 300mm was returned) investigation findings: (b)(4): no device problem found: no issue was found with the manufacturing of the batch (based on the review of the retained production records and evaluation of the sample).Investigation conclusions: (b)(4): cause not established: the root cause of the reported defect could not be determined.Vascutek ltd.Considers this event as 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, if an adverse trend develops action may be taken at that time.

Event Description

Gelsoft plus straight (cat 633006p-g, lot 17877209, s/n (b)(4)) graft leakage was reported during use.The clinician compressed the graft (at the leak site) to arrest the leak.This resulted in the graft occluding and the subsequent explantation of the graft.The gelsoft branded device was replaced with a gore manufactured ptfe graft.

Event Description

Gelsoft plus straight (cat 633006p-g, lot 17877209, s/n (b)(6)) graft leakage was reported during use.The clinician compressed the graft (at the leak site) to arrest the leak.This resulted in the graft occluding and the subsequent explantation of the graft.The gelsoft branded device was replaced with a gore manufactured ptfe graft.

Manufacturer Narrative

An error was identified in section d6(b) whereby the explant date was entered as (b)(6) 2021, this date is incorrect.The actual date of explantation was (b)(6) 2021.

• Brand Name: GELSOFT PLUS
• Type of Device: GELSOFT PLUS STRAIGHT
• Manufacturer (Section D): ROYAL MELBOURNE HOSPITAL; 3 grattan st; parkville, victoria 3050 ; AS 3050
• MDR Report Key: 12390666
• MDR Text Key: 268929289
• Report Number: 9612515-2021-00022
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881115207
• UDI-Public: 05037881115207
• Combination Product (y/n): N
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: GELSOFT PLUS STRAIGHT
• Device Catalogue Number: 633006P-G
• Device Lot Number: 17877209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR