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

Catalog Number 1601-26

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.However, the reported issue was confirmed through photos provided of the device.The lumen of the catheter was observed to have significant stretching.The stretching of the catheter can occur during the operation when attempting to pull out the catheter if significant resistance is experienced.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.Please note that a second report, 1220948-2022-00117, was also submitted related to this incident.

Event Description

It was reported that during a procedure using a tuftex embolectomy catheter that the catheter became immensely elongated while being removed from the patient.A second device was used where the balloon of the catheter ruptured during use.No injury occurred.Please note that a second report, 1220948-2022-00117, was also submitted related to this incident.

• Brand Name: TUFTEX EMBOLECTOMY CATHETER
• Type of Device: 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: 15806936
• MDR Text Key: 307894620
• Report Number: 1220948-2022-00116
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100448
• UDI-Public: (01)00840663100448
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K992368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 1601-26
• Device Lot Number: SLC5507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1