MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. OVER-THE-WIRE EMBOLECTOMY CATHETER 2

Catalog Number 1651-88

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.We observed that the balloon in this catheter had a circumferential rupture and was missing about 3 mm of its balloon piece at its middle region.No other defects were noted on this device.Surgeon had tested the balloon functionality before use and found it be operational.During follow-up with the surgeon, we learned that the device was used to pull an old adherent thrombus.When he attempted to remove the thrombus, he experienced more resistance compared to his previous cases.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.Our quality control inspector had also performed a pull test on a sample of the catheters from this lot number during in-process inspection.All of these units passed the qc requirements and performed as intended when tested to their validated force.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.Surgeon completed the procedure using another lemaitre over-the-wire embolectomy catheter.Please note that we have also submitted another manufacturer's incident report # 1220948-2019-00168 that occurred during this same case prior to the aforementioned incident.

Event Description

During de-clotting of av fistula, when surgeon attempted to remove the thrombus by pulling it through the inflated balloon of over-the-wire thrombectomy catheter, he observed the balloon to have ruptured when it was removed from the patient's vessel.There was no injury to the patient as the result of this incident.This is report 1 of 2.

• Brand Name: OVER-THE-WIRE EMBOLECTOMY CATHETER 2
• Type of Device: EMBOLECTOMY CATHETER
• 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: 9494977
• MDR Text Key: 179297913
• Report Number: 1220948-2019-00169
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100750
• UDI-Public: 00840663100750
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 1651-88
• Device Lot Number: OTW4291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2019
• 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