MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LIFESPAN EPTFE GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number	R06050
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.No injury to the patient.We do not have any other complaints of this nature for the lot.This can be considered an isolated event.Batch record was reviewed for this lot.The lot does not have any non-conformities listed that could relate or contribute to this issue and had passed all our qc tests.Device remains implanted in patient.
Event or Problem Description
During operation of left thigh avbg, doctor used r06050 (lot: lvg1654).Doctor found the graft was permeable only one side which ptfe graft bridge to artery near groin area., she then put drain tube at the sweating side and closed the incision.

• Brand Name: LIFESPAN EPTFE GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• MDR Report Key: 5847852
• Report Number: 1220948-2016-00016
• Device Sequence Number: 796782
• Product Code: DSY
• UDI-Device Identifier: 00840663105199
• UDI-Public: 00840663105199
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K032900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

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: No Information
• Device Expiration Date: 07/30/2021
• Device Catalogue Number: R06050
• Device Lot Number: LVG1654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2016
• Device Age: 2 YR
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1220948-2016-00016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other