MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. DISTAL PERFUSION CATHETER

Model Number 2105-15

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the reported event.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.We have not received any other complaints of a similar nature for devices from this lot.Therefore, we believe that it was an isolated incident.The malfunction occurred during the pre-use check prior to inserting the catheter into the patient.No injury resulted from the event.

Event Description

Balloon of the distal perfusion catheter did not inflate or deflate properly during the pre-testing prior to inserting in the patient.

• Brand Name: DISTAL PERFUSION CATHETER
• Type of Device: DISTAL PERFUSION 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: 15380829
• MDR Text Key: 306199014
• Report Number: 1220948-2022-00094
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 00840663101610
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K032041
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2105-15
• Device Catalogue Number: 2105-25
• Device Lot Number: QDP1012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1