MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC LEMAITRE VALVULOTOME

Model Number 1009-00

Device Problem Difficult to Open or Close (2921)

Patient Problem Laceration(s) (1946)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

We have received the device for evaluation and we have confirmed the reported incident.When we pulled the green handle to close the centering hoops/blades, we observed that one of the blades was protruding out of its retainer slot and didn't seat properly.The centering hoop of this same blade was also found bent.The distance of this retainer slot was measured to be within specification.As instructed in the ifu, the surgeon inspected the blades for proper alignment before the procedure and he found it to be operational.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 likely the blade or the centering hoop was damaged during the procedure influenced by the patient's anatomy/condition since the device was found to be operational during the pre-use check.A batch record review of the affected device could not be performed since the lot number of this device was not provided to us.The surgeon implanted a ptfe graft in the patient since he was unable to use the autologous vein for the bypass.The ifu provides a series of instructions to users to prevent vein lacerations that can occur due to user error.The ifu warning includes: do not insert the lemaitre valvulotome into a vessel or extract from a vessel in the open position.Do not open or close the lemaitre valvulotome while in a coiled configuration.Do not pass the lemaitre valvulotome or lemills valvulotome through a vessel that has undergone synthetic grafting or contains implants.Do not rotate the lemaitre valvulotome in a vessel.Do not use the device for valvulotomy unless the target vein is fully distended by arterial blood flow (due to anastomosis of the artery to vein) or by saline injection.Inspect blades for damage and alignment before use.

Event Description

Valvulotome left a deep groove on the inside of the great saphenous vein (gsv).Surgeon identified that the tip/blade of the valvulotome appeared frayed after use.Surgeon had to implant a ptfe graft since he could not use the gsv for in-situ bypass.

• Brand Name: LEMAITRE VALVULOTOME
• Type of Device: 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 13098774
• MDR Text Key: 287557040
• Report Number: 1220948-2021-00120
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663106653
• UDI-Public: 00840663106653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-00
• Device Catalogue Number: 1009-00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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