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

Model Number	2102-09
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The catheter was used during the replacement of the artificial blood vessel in the thoracoabdominal region.The balloon of the catheter ruptured during the operation.The physician replaced that catheter with another pruitt irrigation occlusion catheter and continued the operation.There was no impact on the patient because of the catheter malfunction.
Additional Manufacturer Narrative
We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the incident.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.Further, 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.There was no harm to the patient because of this incident.The surgeon used another catheter to complete the procedure.

• Brand Name: PRUITT IRRIGATION OCCLUSION CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• MDR Report Key: 12719744
• Report Number: 1220948-2021-00103
• Device Sequence Number: 3984191
• Product Code: DXE
• UDI-Device Identifier: 00840663101535
• UDI-Public: 00840663101535
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 02/28/2026
• Device Model Number: 2102-09
• Device Catalogue Number: 2102-09
• Device Lot Number: PIO1469
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1