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

Model Number	HJL016-30-N
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220948-2022-00104
• Device Sequence Number: 17266432
• Product Code: LXA
• UDI-Device Identifier: 00840663108671
• UDI-Public: 00840663108671
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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: Health Professional
• Device Expiration Date: 01/28/2026
• Device Model Number: HJL016-30-N
• Device Catalogue Number: HJL016-30-N
• Device Lot Number: PVB1146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown