MAUDE Adverse Event Report: VASCUTEK LTD. CANNULA GRAFT; PVC CANNULA WITH GELATIN SEALED EPTFE VASCULAR PROSTHESIS

Model Number	PVC CANNULA
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No information provided on patient condition prior to event other than age and sex.Hospital reported no patient harm due to event.(b)(4).Reported leak from between pvc tube and luer connector.(b)(4).Leak reported to emanate from bond between pvc tube and luer connector.Actual device not evaluated - actual device discarded by hospital after procedure.No testing methods performed - no testing could be performed on device as it was disposed of by hospital and therefore not returned.Process evaluation - evaluation of qc and manufacturing records performed.Manufacturing review - review performed on qc, manufacturing, physical test records, incoming goods inspection records and sub-assembly records assembly and packing review - review of sub- assembly and final assembly records, sterilisation process review - review of sterilisation cycle carried out.No failure detected - review of related qc, manufacturing and associated documentation did not show any issues with manufacture of batch or sub-assembly.All processes carried out to specification.All physical and in-process testing met stipulated acceptance criteria.Of the batch of 140 sub-assembled pvc tube to connector parts used in this batch, twelve were taken and destructively tested.Pull tests were carried out between pvc tube and connector and all met acceptance criteria.Pressure tests were also carried out and no leakage was found on any of the twelve tested.Device discarded by user, unable to follow up.- as the device was discarded by the hospital it was not possible to confirm exact nature of leakage and/or root cause.Unable to confirm complaint - without return of device it is not possible to confirm complaint -no issues were found with batch manufacture or processing.No further complaints have been received to date.In the last 5 years there have been 2 complaints for leakage of a cannula, this one in relation to the area between pvc and connector, and one in relation to leakage between eptfe graft and pvc tube.When compared to cannula sales over last 5 years ((b)(4)) this gives an very low occurrence rate of (b)(4).Vascutek now considers this complaint closed.No further actions required however, the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.Device discarded by hospital.
Event or Problem Description
The event was described to vascutek on 23-nov-16 as follows: a linear crack was noticed in cannula connector.After the device was connected and flow established the cannula was found to be leaking at the crack site, it was approx.1cm, or less, from the luer cap on the connector.A sterile band was used to cover the area and prevent active leak.A small leak remained but the case was completed.No effect on patient, cannula was removed when patient was taken off bypass as per normal procedure.On 28th nov 2016 further information was received from the hospital that the leakage was due to poor connection between plastic tube (pvc) and luer lock connector rather than crack in connector.

• Brand Name: CANNULA GRAFT
• Common Device Name: PVC CANNULA WITH GELATIN SEALED EPTFE VASCULAR PROSTHESIS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• MDR Report Key: 6192547
• Report Number: 9612515-2016-00031
• Device Sequence Number: 10795920
• Product Code: DWF
• UDI-Device Identifier: 05037881009537
• UDI-Public: 05037881009537
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K081560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/21/2016
• Report Date (Section F): 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: PVC CANNULA
• Device Catalogue Number: CGS2008S
• Device Lot Number: 14892510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2016
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/21/2016
• 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
• Patient Age: 56 YR