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

Model Number	1651-48
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
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 longitudinal hole of about 2 mm in its balloon.No other defects were noted on this device.All of the balloon parts remained intact.Both inflation and irrigation lumen flushed properly when liquid was injected through the other end.The malfunction occurred during the second pass when the surgeon attempted to remove the residual clot from the patient's femoral artery.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.Based on our observation of the returned device, it is possible that some anatomical ( calcification or stenosis in the lesion area ) or procedural factors ( use of excessive force to remove the thrombus) may have contributed to the balloon rupture.Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque or overinflated balloon.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.There was no injury to the patient as the result of this incident.
Event or Problem Description
During an embolectomy procedure, the balloon of a over-the-wire embolectomy catheter burst when surgeon attempted to remove a clot from the patient's superficial femoral artery.There was no injury to the patient as the result of this incident.

• 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: 9729588
• Report Number: 1220948-2020-00020
• Device Sequence Number: 14004560
• Product Code: DXE
• UDI-Device Identifier: 00840663100682
• UDI-Public: 00840663100682
• 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): 02/19/2020

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: 07/28/2024
• Device Model Number: 1651-48
• Device Catalogue Number: 1651-48
• Device Lot Number: OTW3937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1