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

Catalog Number	1009-00
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We observed multiple kinks in the shaft of the catheter.When we attempted to actuate the blades, the centering hoops opened partially.At this position, we observed all of the blades were properly retained inside its retainer slots.When the device was closed, we observed the gap distance between the end of the retainer and the tip of the sheath was above our specification.When we opened and closed the centering hoops multiple times, we also observed a blade was intermittently protruding out of its retainer slot.Based on our device evaluation, it is likely that this device was handled very aggressively by the user that led to multiple kinks in this device and eventually resulted in this malfunction.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.There was no injury to the patient as the result of this incident.
Event or Problem Description
During valvulotomy, surgeon was unable to close the valvulotome properly.There was no injury to the patient as the result of this incident.No further information was provided by the surgeon.

• Brand Name: HYDRO LEMAITRE VALVULOTOME
• Common Device Name: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 9469476
• Report Number: 1220948-2019-00166
• Device Sequence Number: 13031081
• Product Code: MGZ
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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: 02/28/2024
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH1627V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1