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

Catalog Number	2102-09
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The reported issue was confirmed.The balloon of the device was observed to be ruptured.While the reported event was confirmed, the exact root cause of the balloon rupture could not be determined.It is possible for anatomical conditions like stenosis to increase the chance of balloon rupture during operation.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.
Event or Problem Description
It was reported that the pruitt irrigation occlusion catheter balloon ruptured while attempting to use it to occlude vessel.It did not hold fluid to occlude vessel, even on first pass.It was unsure if the product was tested prior to use.No injury was reported to 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 ; 7814251683
• MDR Report Key: 18790728
• Report Number: 1220948-2024-00054
• Device Sequence Number: 20791529
• Product Code: DYG
• UDI-Device Identifier: 00840663101535
• UDI-Public: (01)00840663101535
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K811276
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

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 Catalogue Number: 2102-09
• Device Lot Number: QPI1058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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