MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. 2.0 MM OVER-THE-WIRE LEMAITRE VALVULOTOME

Catalog Number	1005-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the complaint device for evaluation since the device has been discarded by the hospital.Hence, we could not conclusively determine the root cause of the defect.Our lot history records review for this lot number did not reveal any discrepancies related to the complaint event either in the manufacturing or the packaging processes.Further, we have not received any other complaints of a similar nature for devices from this lot.Therefore, we believe that it was an isolated incident.Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process.Our quality control also samples these devices before final packaging to ensure proper blade adjustment.It is possible the blade or the centering hoop was damaged during the procedure influenced by patient's anatomy/condition or the operator's manipulation of the device during use since the device was found to be operational during preuse check.Our ifu properly warns users not to rotate the device in a vessel and not to advance the centering hoops in an open configuration as it may cause injury to the vein.Surgeon sutured the cut section of the vein using 6.0 prolene.Sales rep.On (b)(6) 2018 stated that the patient was doing fine in regards to the bypass.
Event or Problem Description
During femoral posterior tibial in-situ bypass, the cutting blades of the valvulotome cut the great saphenous vein about 4-5 cm above the distal end.6.0 prolene was used to suture the cut section of the vein.

• Brand Name: 2.0 MM OVER-THE-WIRE LEMAITRE VALVULOTOME
• Common Device Name: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7975612
• Report Number: 1220948-2018-00084
• Device Sequence Number: 201584
• Product Code: MGZ
• UDI-Device Identifier: 00840663100132
• UDI-Public: 00840663100132
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K132190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 1005-00
• Device Lot Number: ELV61045V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention