MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PROCOL VASCULAR BIOPROSTHESIS; TISSUE GRAFT OF 6MM AND GREATER

Model Number HJL016-30-N

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

According to the surgeon, a procol vascular bioprosthesis was being prepared for use and a hole in the graft was found when they opened the package.The container was still sealed when the hole was observed and the product was not used on the patient.The product was discarded by the hospital.

Manufacturer Narrative

It was reported that the procol vascular bioprosthesis had a hole in the graft when the package was opened.The product was not returned, therefore the reported event could not be confirmed and the root cause could not be determined.Review of the lot history record did not find any issues that could cause the reported issue.Further, we have not received any other reports of similar incidents from this lot.

• Brand Name: PROCOL VASCULAR BIOPROSTHESIS
• Type of Device: TISSUE GRAFT OF 6MM AND GREATER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 15498800
• MDR Text Key: 306358975
• Report Number: 1220948-2022-00104
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00840663108671
• UDI-Public: 00840663108671
• 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: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HJL016-30-N
• Device Catalogue Number: HJL016-30-N
• Device Lot Number: PVB1146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• 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