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

Model Number	ATC1520
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not available for return.Review of the available information determined the issue is due to a user error.The nurse did not properly follow the handling instructions on the package and inadvertently introduced the non-sterile package into the sterile field.The ifu also provides the following warnings related to this issue: albograft vascular grafts are supplied sterile through a double sterile barrier.The internal container is externally sterile provided that the external container has been neither damaged nor opened.The external container is only internally sterile: it must not be brought into a sterile environment.Caution: do not bring the external container into the sterile environment.Remove the graft using an aseptic procedure.While this issue was determined to be a user error, a capa has been initiated as a preventative measure to review the device packaging.Review of the lot history record found no issues for this lot.The device packaging provides various warnings on the package to instruct the user how to avoid this issue.
Event or Problem Description
During a meeting with the swedish moh we were informed of an incident where while preparing the albograft, the nurse overlooked the labels on the packaging and introduced the non-sterile packaging into the sterile field.The status of the patient is unknown.The nurse did not report the event at the time of the event.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT
• 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: 16762228
• Report Number: 1220948-2023-00057
• Device Sequence Number: 14950412
• Product Code: MAL
• UDI-Device Identifier: 00840663103867
• UDI-Public: (01)00840663103867
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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 Model Number: ATC1520
• Device Catalogue Number: ATC1520
• Device Lot Number: 197618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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