MAUDE Adverse Event Report: VASCUTEK LTD. CANNULA GRAFT; EPTFE CANNULA GRAFT

Model Number	CANNULA GRAFT
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information was received.Device returned on 15-sep-2017 however evaluation not complete at time of this submission.(b)(4).Once investigation is complete, results of investigation will be reported in next follow up/ final report.
Event or Problem Description
The event was reported to vascutek as follows: cannula graft was leaking and weeping fluid.Patient converted onto full extracorporeal membrane oxygenation (ecmo) with cannula still in place.- delay in medical procedure however no reported patient effect.
Additional Manufacturer Narrative
Actual device evaluated - a small section (80mm length) of the complaint device was returned for investigation.Device from reserve sample evaluated - a graft manufactured in 2015 and a graft manufactured in sept 2017 were retrieved and tested for porosity with blood as actual device sample was too short for this test.Fluid pressure testing - retrieved grafts were tested for porosity with blood using citrated horse blood under 120mmhg pressure.Visual inspection - returned sample visually inspected image inspection - returned sample was decontaminated and visually inspected on both outer and inner surfaces by eye.Microscopic inspection - returned sample was examined under magnification scanning probe microscopy - returned sample was prepared and examined under scanning electron microscope.No failure found - evaluation of the returned sample could not find any issue with the physical structure of the device which would have led to leakage seen.Labelling problem - on review of the investigation it was found that the most likely cause of the leakage seen was exposure of the eptfe graft to oil, alcohol solutions which affect the hydrophobic properties of the graft.Although the site has indicated that no alcohol based wipes were applied to the graft from the evidence in the video provided and results of evaluation this does not seem to be the case.This precaution, however, is not indicated on the current ifu for this product.Labelling deficiency - current usa ifu for cannula graft does not contraindicate or indicate as a precaution that oil, alcohol, aqueous solution should not be applied to graft.Vascuteks investigation found the following: the review of manufacturing records and qc test results showed that the batch was manufactured to specification.A 5-year review of similar complaints (leakage of cannula grafts) gave a low occurrence rate of 0.08%.Only 3 leakage events in total - only this complaint for this failure mode.There have been no similar complaints received from other units of this batch the evaluation carried out indicated that an oil or alcohol based product was used on device affecting the hydrophobic properties of the device.Vascutek is currently in process of updating its range of ifu's in relation to ongoing changes in the source of materials for gelatin production.Additional actions will be raised to have the relevant ifu's updated with information relating to use of oil or alcohol based product being applied to grafts.No other actions are planned at this time 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.(b)(4).

• Brand Name: CANNULA GRAFT
• Common Device Name: EPTFE CANNULA GRAFT
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6875048
• Report Number: 9612515-2017-00016
• Device Sequence Number: 1312791
• Product Code: DWF
• UDI-Device Identifier: 05037881009537
• UDI-Public: 05037881009537
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017
• Report Date (Section F): 08/22/2017

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: 12/31/2018
• Device Model Number: CANNULA GRAFT
• Device Catalogue Number: CGS2008S
• Device Lot Number: 15989066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2017
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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