MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. 1.5 HYDRO LEMAITRE VALVULOTOME

Catalog Number 1009-00

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated on 1/4/2017.When we inspected the blades, we found one of the blade was sticking out the retainer cap.This likely have caused the blade to get stuck into the wall of the vessel while inserting/removing the device in the closed position.We found out from our evaluation that different blades get stuck depending upon the way blades are rotated.We also noticed that the cut at the end of the sheath was not perpendicular.Poor tweaking of the blades during the manufacturing process along with the skewed cut at the end of the sheath are likely root cause of this defect as skewed cut of the sheath can prevent all the blades from closing at the same time.Please note that we do conduct 100% inspection of the blade during assembly process.Our review of the lot history records for this lot did not find any discrepancies that in either the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of similar nature for devices from this lot.Therefore, we believe that it was an isolated event.

Event Description

During pre-use check, one of the blade was found to be sticking out of the retainer cap when the device was closed.However, device was still used in the patient.During the procedure, the blade got stuck in the vein of the patient.So, they had to cut the device in two pieces.Proximal anastomosis was opened again to retrieve the valvulotome.Since they cut the valvulotome in half when it got stuck and retrieved it from the patient's vein, there was no injury to the patient.So, the patient has the normal post-operative healing time and was discharged from the hospital.

• Brand Name: 1.5 HYDRO LEMAITRE VALVULOTOME
• Type of Device: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 2nd ave; burlington MA 02148
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 2nd ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 2nd ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 6237393
• MDR Text Key: 64767403
• Report Number: 1220948-2017-00001
• Device Sequence Number: 1
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: 00840663106653
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH1119V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention