MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. 1.8 EXPANDABLE LEMAITRE VALVULOTOME

Catalog Number	1000-90
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported defect in this device.We found that one of the blades did not close into the retainer when the green handle was pulled.The gap distance and the sheath length was found to be within specification.We also noted that the hoop of this blade was bent which could have led to this issue.Our lot history records review for lot number elv32331v did not reveal any discrepancies related to the complaint event either in the manufacturing or packaging processes.We have also reviewed the complaint history records for this product line for the last three years.We have not received any other complaints related to a similar issue.Hence, we consider this to be an isolated incident.Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process.Our quality group also inspects each device before final packaging to ensure proper blade adjustment.However, it is possible that this blade/hoop was not well aligned during the manufacturing process.The blade alignment process includes manual adjustment of each blade by the operator.Operator errors, though rare, are possible due to the manual nature of the adjustments.It is also possible that the hoop was damaged during packaging or during shipping the device to the hospital.Our ifu clearly informs users to inspect the blades for damage and alignment prior to use.In this case, the user properly followed the risk mitigation measures (ifu) and properly identified the issue.Device was not used in the patient.Another valvulotome was used for the surgery.
Event or Problem Description
One of the four cutting blades of the valvulotome did not close properly into its housing.The malfunction was detected during pre-use check.So, the defective device was replaced with a new valvulotome.

• Brand Name: 1.8 EXPANDABLE LEMAITRE VALVULOTOME
• Common Device Name: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8210317
• Report Number: 1220948-2019-00002
• Device Sequence Number: 19519358
• Product Code: MGZ
• UDI-Device Identifier: 00840663100095
• UDI-Public: 00840663100095
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K980723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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: 06/28/2022
• Device Catalogue Number: 1000-90
• Device Lot Number: ELV32331V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2018
• Initial Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1