MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. HYDRO EXPANDABLE LEMAITRE VALVULOTOME; VALVULOTOME, EXTERNAL VEIN STRIPPER

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/27/2016

Event Type  malfunction  

Manufacturer Narrative

The device was discarded and therefore not available for evaluation, however a picture of the device was submitted with the complaint.While we cannot determine conclusively the cause of the reported failure, this issue is most consistent with a failure of the valvulotome to perform as expected.Device discarded by physician.

Event Description

The customer reported that during a non-reversed bypass the physician felt resistance when pulling the catheter.He tried to close the blades into the sheath but could not.He pulled the catheter and cut the distal end of the vein.

• Brand Name: HYDRO EXPANDABLE LEMAITRE VALVULOTOME
• Type of Device: VALVULOTOME, EXTERNAL VEIN STRIPPER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second avenue; burlington, MA 01803 ; 7812212266
• MDR Report Key: 6206545
• MDR Text Key: 63371956
• Report Number: 1220948-2016-00025
• Device Sequence Number: 1
• Product Code: MGZ
• UDI-Device Identifier: 00080663106653
• UDI-Public: 0080663106653
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH1113V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Other