MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT IRRIGATION OCCLUSION CATHETER

Model Number	2102-09
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was tested and the reported balloon deflation issue was confirmed.During testing the balloon inflated at the lower portion of the balloon which allowed it to inflate, but the inflated portion remained below the skive holes of the lumen.As a result, the balloon was unable to deflate.Further testing found the distal skive hole to be off center, which resulted in restricted fluid flow and caused the balloon to only inflate at the lower portion of the balloon assembly.While fluid was able to enter through each of the skive holes, the manufacturing error prevented the fluid from exiting from the skive holes as intended resulting in the reported issue.The lot number of the product was not provided.Therefore, we're unable to perform a lot review.
Event or Problem Description
It was reported the pruitt irrigation occlusion catheter balloon didn't deflate.No injury reported to patient as the device was not directly used on the patient.

• Brand Name: PRUITT IRRIGATION OCCLUSION CATHETER
• Common Device Name: OCCLUSION 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: peter song ; 63 second ave; burlington, MA 01803
• MDR Report Key: 17362430
• Report Number: 1220948-2023-00120
• Device Sequence Number: 5289869
• Product Code: DQT
• UDI-Device Identifier: 00840663101535
• UDI-Public: (01)00840663101535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K880231
• 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 Assistant
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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: 2102-09
• Device Catalogue Number: 2102-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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