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

Model Number	1601-38
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure using a tuftex embolectomy catheter the initial catheter became immensely elongated while being removed from the patient.After the first device was removed, a second device was used where the balloon of the catheter ruptured during use.No injury occurred.Please note that report 1220948-2022-00116 was also submitted related to this incident.
Additional Manufacturer Narrative
The product was not returned for evaluation.However, the reported issue was confirmed through photos provided of the device.The balloon of the device was observed to be ruptured.It could not be detemined what caused the balloon to rupture.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.Additionally, we have not received any reports of similar issues occurring for this lot.The ifu for the device defines possible risks associated with the use of this product including balloon rupture.Please note that report 1220948-2022-00116 was also submitted related to this incident.

• 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: 15807238
• Report Number: 1220948-2022-00117
• Device Sequence Number: 5616030
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: (01)00840663100477
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/16/2022

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: 1601-38
• Device Catalogue Number: 1601-38
• Device Lot Number: QSL1094
• 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: 10/18/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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