MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. OVER-THE-WIRE EMBOLECTOMY CATHETER

Model Number	1651-38
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported failure.We observed a circumferential rupture on the balloon.We observed about 5 mm of the balloon piece at the middle was missing.Based on our device evaluation, it is likely that the balloon of this catheter was either over-inflated or the balloon came in contact with a sharp object during inflation process and led to balloon rupture during pre-use check.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.Hence, we consider this to be an isolated incident.Device did not come in contact with patient.
Event or Problem Description
During pre-use check, the balloon of an over-the-wire embolectomy catheter burst when surgeon attempted to inflate the balloon with saline.Device did not come in contact with the patient.

• Brand Name: OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• MDR Report Key: 10228452
• Report Number: 1220948-2020-00071
• Device Sequence Number: 10899627
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: 00840663100668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2020

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: 08/28/2025
• Device Model Number: 1651-38
• Device Catalogue Number: 1651-38
• Device Lot Number: OTW4279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1