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	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pruitt irrigation occlusion catheter balloon failed to deflate during the pre-use check.The device was not used for the procedure.
Additional Manufacturer Narrative
The product was received for evaluation and the reported issue was confirmed.When the balloon was inflated the balloon failed to deflate.The balloon was removed from the device and the skive hole was inspected.The skive hole was not completely cut and the cut material was not removed from the catheter lumen.As a result, the material remained covering the skive hole.This allowed fluid to fill the balloon, but created a blockage and prevented the balloon from deflating.This issue is due to a manufacturing error.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.

• 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16742964
• Report Number: 1220948-2023-00053
• Device Sequence Number: 5347801
• 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
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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
• Device Lot Number: QPI1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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