MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PROCOL BIOLOGIC VASCULAR GRAFT, 6MM X 40 CM; TISSUE GRAFT

Model Number	HJL016-40-N
Medical Device Problem Codes	Fluid/Blood Leak (1250); Physical Property Issue (3008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation but since it had been prepped for use and exposed to blood/preservatives we were unable to reach any conclusions from our investigation.The device history record for this lot was reviewed.The lot passed all inspection criteria including: visual inspection, external diameter, and leak testing at simulated physiological pressure.This is a bioprosthetic device and variation along the graft is normal.Our ifu does state that a "small amount of oozing is acceptable".At this time we are unable to determine the cause of the incident but believe it was an isolated event.
Event or Problem Description
During implantation of the graft, the surgeon pressurized it and noticed that a one inch section near the end appeared thin, lighter in color and started to slightly leak.The doctor removed the graft and used a different graft in stock without further incident.

• Brand Name: PROCOL BIOLOGIC VASCULAR GRAFT, 6MM X 40 CM
• Common Device Name: TISSUE GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 5970207
• Report Number: 1220948-2016-00021
• Device Sequence Number: 19037155
• Product Code: LXA
• UDI-Device Identifier: 00840663108688
• UDI-Public: 00840663108688
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020049
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2016

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: Physician
• Device Expiration Date: 12/30/2019
• Device Model Number: HJL016-40-N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2016
• Initial Report FDA Received Date: 09/22/2016
• 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