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

Model Number	GELWEAVE STRAIGHT
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative health effect - clinical code 4582 - no clinical signs, symptoms or conditions - no patient involvement - site reported no patient consequence health effect - impact code.2645 - no patient involvement - no patient involvement when the adverse event occurred - replacement device located prior to procedure commencement.Medical device problem code 1318 - labelling, instructions for use or training problem - mislabelling 2911 - device markings/labelling problem - product was incorrectly labelled during rework operation.4051 - inaccurate information - product was placed in blister for a valsalva graft being reworked in the same area on same day.Component code 4755 - part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or sub-assemblies - graft is a single tube of material with no additional sub-assemblies.Type of investigation 10 - testing of actual/suspected device - both the complaint device and twin device from mix up have been returned to vascutek ltd.4109 - historical data analysis - a review of similar mislabelling events in the field was performed and found an occurrence rate of 0.0006% across all products.3331 - analysis of production records - the investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.- review of production records showed that the device was returned for resterilisation after a soiled tyvek was found post sterilisation - records showed that 4 valsalva's were also reworked on the same day.Further investigation showed that these 4 devices were shipped to italian distributor.4111 - communication/interviews - communication with the italian distributor found that three devices were already used in procedures without any report of an issue.The 4th device was checked and found to be the straight graft which had been swapped.Investigation findings 170 - manufacturing process problem identified - an issue was identified with product segregation during the rework process.4245 - packaging contains incorrect device - information and images received identified that the incorrect product was within the packaging.Further investigation located and identified the other device which had been incorrectly packaged.Both devices have been returned to vascutek ltd.And confirmed these two devices were swapped at rework as suspected.Investigation conclusion 25 - cause traced to manufacturing - cause was traced to inadequate controls during cleanroom packaging of devices and rework devices.Vascutek has recovered both devices and they have been returned to vascutek.This event will be addressed via an ongoing capa raised to address product mix up.No further investigation or actions are required for this event and vascutek ltd.Now considers this complaint closed.-.
Event or Problem Description
Event was reported to vascutek ltd.On (b)(6) 2020: the package indicated a gelweave straight tube graft 733010.After opening the box and foil pouch it turned out that instead of the tube graft there was a gelweave valsalva inside the inner blister.The customer opened another box instead.No consequences for the patient.

• Brand Name: GELWEAVE
• Common Device Name: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 11122389
• Report Number: 9612515-2021-00001
• Device Sequence Number: 677575
• Product Code: DSY
• UDI-Device Identifier: 05037881105147
• UDI-Public: 05037881105147
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: GELWEAVE STRAIGHT
• Device Catalogue Number: 733010-G
• Device Lot Number: 17722331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other