MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE STRAIGHT

Model Number GELWEAVE STRAIGHT

Device Problem Material Integrity Problem (2978)

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

Event Date 07/11/2021

Event Type  malfunction  

Manufacturer Narrative

Health effect: clinical code: (b)(4): no clinical signs or symptoms.Health effect: impact code: (b)(4): no health consequences or impact.Medical device problem code: (b)(4): material integrity problem reported.Component code: (b)(4): term not applicable.Type of investigation: (b)(4): analysis of production records: a review of the retained manufacturing and quality control records confirmed that this batch was manufactured to the intended specifications.Specific emphasis was directed toward the porosity results, which clearly indicate within spec.Results.Max flow 26ml/min, results from the batch, 11/11 units, passed the test.(lowest test result 3ml/min, highest 18ml/min).Type of investigation: (b)(4): trend analysis: review of similar complaints of leakage for all gelweave branded devices gave an occurrence rate of (b)(4).No negative trend was identified.Type of investigation: (b)(4): communication/interviews: information provided by the site was that the patient was anticoagulated normally, no unusual tension was applied to the device; however; the site also advised that the graft was not presoaked in saline prior to use.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.Investigation findings: (b)(4): no device problem found - no structural defect was found with the graft during inspection and no issues were found during the review of the retained manufacturing records for the batch.Investigation conclusions: (b)(4): conclusion is not yet available as the sample has not yet been received and inspected by (b)(4).Investigation conclusions: (b)(4): use error caused or contributed to the event: the graft was not presoaked for the 5 mins stipulated within the ifu; this may have been contributed to the reported issue.

Event Description

On (b)(6) 2021 the facility that was using the gelweave graft reported that it was leaking (porous).The excess blood was suctioned away and the procedure was completed without further issue.

Event Description

On (b)(6) 2021 the facility that was using the gelweave graft reported that it was leaking (porous).The excess blood was suctioned away and the procedure was completed without further issue.

Manufacturer Narrative

Corrected data from initial report - section h10 - investigation findings code 3233 - should have stated results pending completion of the analysis of the device upon its return.Section h3 - returned product analysis summary is as follows: a graft sample measuring 55mm in length was returned.The diameter was confirmed as 8mm (consistent with the catalogue no.).A textiles analysis and sem (scanning electron microscopy) evaluation of the structure identified no abnormalities in the weave of the device and no damage was detected.Porosity/permeability testing of the fabric passed the test at the lower end of the scale.In conclusion, there is no evidence of any damage, holes or tears to the fabric which could have caused the issue observed by the user.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.Manufacturer narrative: section h6.Health effect - clinical code - 4582 - no clinical signs or symptoms.Health effect - impact code - 2199 - no health consequences or impact.Medical device problem code - 2978 - material integrity problem reported.Component code - 4755 - term not applicable type of investigation - 3331 - analysis of production records - a review of the retained manufacturing and quality control records confirmed that this batch was manufactured to the intended specifications.Specific emphasis was directed toward the porosity results, which clearly indicate within spec.Results.- max flow 26ml/min - results from the batch, 11/11 units, passed the test.(lowest test result 3ml/min, highest 18ml/min).Type of investigation - 4110 - trend analysis - review of similar complaints of leakage for all gelweave branded devices gave an occurrence rate of (b)(4).No negative trend was identified.Type of investigation - 4111 - communication/interviews - information provided by the site was that the patient was anicoagulated normally, no unusal tension was applied to the device; however; the site also advised that the graft was not presoaked in saline prior to use.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.Investigation findings - 213 - no device problem found - no structural defect was found with the graft during inspection and no issues were found during the review of the retained manufacturing records for the batch.Investigation conclusions - 61 - use error caused or contributed to the event - the graft was not presoaked for the 5 mins stipulated within the ifu; this may have been contributed to the reported issue.Investigation conclusions - 67 - no product defect was detected during the inspection and evaluation of the returned sample.

• 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
• MDR Report Key: 12317323
• MDR Text Key: 266397767
• Report Number: 9612515-2021-00020
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881105130
• UDI-Public: 05037881105130
• Combination Product (y/n): N
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 733008-G
• Device Lot Number: 21627312
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other