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

Catalog Number	1651-34
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for investigation.However, the provided photo confirmed the report.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.As stated in the ifu: avoid extended or excessive exposure to fluorescent light, heat, sunlight or chemical fumes to reduce balloon degradation.Do not grasp the balloon with instruments at any time to avoid damage to the latex.Caution: do not exceed the maximum recommended volume, as over inflation increases the possibility of balloon rupture.Due to the increased rate of occurrence of this issue a capa has been opened to further investigate the issue.We have conducted a lot of history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.
Event or Problem Description
It was reported that the tuftex otw balloon ruptured during pre-use check.It was not used on the patient.No injury was reported to the patient.

• 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 20260484
• Report Number: 1220948-2024-00183
• Device Sequence Number: 12613794
• Product Code: DXE
• UDI-Device Identifier: 00840663100651
• UDI-Public: (01)00840663100651(11)200826(17)260728(10)OTW4570(91)1651-34
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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: 07/28/2026
• Device Catalogue Number: 1651-34
• Device Lot Number: OTW4570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2020
• 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