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

Model Number	1651-84
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tuftex otw embolectomy catheter balloon burst during use on the patient.No injury was reported.
Additional Manufacturer Narrative
The complaint device was received for evaluation and the reported event was confirmed.The balloon was observed ruptured upon return.While the reported issue was confirmed, the precise cause for the damage is unknown.No patient injury was reported as a result of the issue.Balloon ruptures are possible due to the nature of the procedure this device is used for.Our ifu provides the following warning related to the possibility of balloon ruptures: arterial rupture or balloon failure due to sharp calcified plaque may occur.The possibility of balloon rupture must be taken into account when considering the risks involved in the catherization procedure.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.

• Brand Name: TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16140537
• Report Number: 1220948-2023-00001
• Device Sequence Number: 12466688
• Product Code: DXE
• UDI-Device Identifier: 00840663100743
• UDI-Public: (01)00840663100743
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K022145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2023

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: 02/28/2025
• Device Model Number: 1651-84
• Device Catalogue Number: 1651-84
• Device Lot Number: QOT1460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown