MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TUFTEX EMBOLECTOMY CATHETER

Model Number	1601-44
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for evaluation.While it was initially reported that a the balloon failed to inflate, the inspection found that the balloon was ruptured.It is possible for the balloon to rupture due to physiological conditions of the patient encountered during the procedure.The lot history record for the device was reviewed, no issues were found that would cause or contribute to the reported event.Additionally, we have not received any reports of similar issues occurring for this lot.The ifu provides warnings of various possible causes of balloon ruptures during use.
Event or Problem Description
It was initially reported that when using the tuftex embolectomy catheter the balloon of the catheter was unable to inflate.However, the device investigation was performed on 05jan2023, and it was determined that the balloon of the device was ruptured.Based on the investigation findings, this incident was updated to a reportable incident with awareness date of 05jan2023.

• Brand Name: TUFTEX 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: 16293324
• Report Number: 1220948-2023-00008
• Device Sequence Number: 17710397
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: (01)00840663100484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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 Model Number: 1601-44
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC5524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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