MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE VALVULOTOME

Model Number	1009-00
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and the reported incident was confirmed.When the blades were retracted, one of the blades was observed protruding out of the retainer slot and did not sit properly in the slot.The blade was misaligned preventing it from properly inserting into its retainer slot.The root cause of this issue was determined to be centering hoop to wire welding error along with operator adjustment error.During the welding process, this centering hoop was likely not properly aligned against its retainer slot.The blade process includes manual manipulation of each blade by the operator.Operator errors are possible due to the manual nature of the adjustments.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.Further, we have not received any other complaints of a similar nature for devices from this lot.A corrective and preventive action (capa) has been opened to address this issue.
Event or Problem Description
It was reported that a lemaitre valvulotome was defective when removed from the sterile packaging.The anterior cone could not be completely pulled into the shaft and a knife blade protruded into the vascular lumen.There was no injury reported for this issue.

• Brand Name: LEMAITRE VALVULOTOME
• Common Device Name: VALVULOTOME
• 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: 15735329
• Report Number: 1220948-2022-00115
• Device Sequence Number: 2983830
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: (01)00840663106653
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140042
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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 Model Number: 1009-00
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH2100V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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