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

Model Number	1601-44
Medical Device Problem Codes	Unintended Movement (3026); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the balloon was not able to inflate, so a different device was used for the operation.However, when the product was received it was found that the returned device had the ligature of the balloon slipped toward the distal end of the catheter, which prevented the balloon from deflating.The balloon failing to deflate can potentially cause injury to the patient or require the surgeon to manually pop the balloon to prevent injury.
Additional Manufacturer Narrative
The initial report stated that the balloon was unable to inflate during the pre-use check, which was deemed a not reportable incident.Upon receiving and investigating the device on 16sep2022, the ligature was observed displaced toward the distal end of the catheter.This resulted in the balloon failing to deflate.Due to the failure, the reporting decision was updated to a reportable event.The force of pulling the catheter during the procedure caused the ligature to slip toward the distal end of the catheter.This allowed the balloon to move past the skive hole in the catheter and prevented the balloon from deflating.No stretching or necking was observed along the catheter lumen.No patient injury was reported.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.

• 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: 15606379
• Report Number: 1220948-2022-00109
• Device Sequence Number: 2200390
• 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): 10/14/2022

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: 1601-44
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC5515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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