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

Model Number	2105-15
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220948-2022-00094
• Device Sequence Number: 5876382
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 00840663101610
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K032041
• 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): 09/08/2022

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 Expiration Date: 04/28/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown