MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT POLYESTER VASCULAR GRAFT; VASCULAR GRAFT PROTHESIS

Model Number	ATC2211
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the graft for evaluation since the section of the graft containing the hole was discarded by the surgeon.The remaining portion of the graft has been implanted in the patient.However, we have observed the reported incident in the video that was provided to us.We observed a small hole in the graft when user flushed the graft with saline.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.During the manufacturing process, the exact graft was inspected by a quality control inspector for holes, broken threads, and any loose fibers in the graft.No defect was noted during the inspection process.A sample of grafts from this lot number were also tested for water permeability and puncture test.All of the samples met its specification.Further, we have not received any other complaints of a similar nature from this lot.Due to the product being discarded a root cause could not be determined.It is possible that this section of the graft came in contact with a sharp object during the procedure which could have damaged the graft.
Event or Problem Description
An implant of albograft amc3008 for bypass was in process.At the distal part of the graft, they found a small hole.This part was not aimed to be used, so it was cut off and was not used.Conclusion a small hole in the graft was recognized, but it was not in contact or been used in the patient.The graft was discarded by the hospital.There was no injury reported.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT PROTHESIS
• 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: 15456844
• Report Number: 1220948-2022-00100
• Device Sequence Number: 7011351
• Product Code: MAL
• UDI-Device Identifier: 00840663104239
• UDI-Public: 00840663104239
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/21/2022

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: 07/28/2025
• Device Model Number: ATC2211
• Device Catalogue Number: AMC3008
• Device Lot Number: 330883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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