MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PROCOL BIOLOGIC VASCULAR GRAFT

Model Number	HJL016-40-N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received and investigated the complaint device for reported incident.We have confirmed the defect.We found that the device was oozing with some permeability from one point nearer to one end from the graft.This is a bioprosthetic device and variation along the graft is normal.Our ifu does state that a "small amount of oozing is acceptable".All grafts are subjected for leak testing prior to acceptance into inventory.
Event or Problem Description
When the surgical tech was flushing the graft, he noticed the graft was leaking from the midpoint of the graft.So, he clamped the distal end and lightly flushed the graft, which then showed diffuse weeping from multiple areas.No obvious defect was noted.The graft was then discarded and then another graft was used.The graft was not used in the patient.

• Brand Name: PROCOL BIOLOGIC VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 6207935
• Report Number: 1220948-2015-00026
• Device Sequence Number: 18956858
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2016

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: 11/25/2019
• Device Model Number: HJL016-40-N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/27/2016
• 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: Required Intervention