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

Model Number HJL016-40-N

Device Problems Fluid/Blood Leak (1250); Physical Property Issue (3008)

Patient Problem No Information (3190)

Event Date 08/23/2016

Event Type  malfunction  

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 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
• Type of Device: TISSUE GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): HANCOCK JAFFE LABS; 70 doppler; irvine CA 92618
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 5970207
• MDR Text Key: 55720195
• Report Number: 1220948-2016-00021
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00840663108688
• UDI-Public: 00840663108688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other