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

Catalog Number	1651-38
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation.The balloon would not inflate during testing.The catheter was cut and inspected; no blockage or foreign material was observed blocking the inflation lumen and fluid was still unable to pass through the catheter.The y-connector was observed and fluid was unable to pass through the y-connector indicating a blockage was present in the y-connector.The device was cut approximately half way down the length of the y-connector and fluid was then able to pass through the inflation lumen.While the reported issue was confirmed it could not be determined if the blockage occurred during manufacturing or while handling the device.No inflation issues were noted during manufacturing that would indicate a blockage was present during quality inspection.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.We have not received any similar complaints related to this lot number.
Event or Problem Description
The balloon did not work unless it was inflated and deflated much stronger than usual during inflation and deflation check.Therefore, the catheter was replaced with a new one.The operation was successfully completed afterwards.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: 17825058
• Report Number: 1220948-2023-00169
• Device Sequence Number: 2343195
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: (01)00840663100668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2023

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 Catalogue Number: 1651-38
• Device Lot Number: OTW4861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2022
• 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