MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT AORTIC OCCLUSION CATHETER; OCCLUDER, CATHETER TIP

Model Number	2100-12
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We observed the tyvek lid was completely sealed to the product tray.The seal marks on the flanges of the trays were complete and uniform confirming that the trays were properly sealed during our packaging process.The devices were returned to us without the foil pouch.Even before opening the package, we can see the balloon of this catheter was damaged due to degradation.This complaint unit was sold to this hospital more than 3 years ago.Since natural rubber latex is affected by environmental conditions, these catheters are packaged in the foil pouch to achieve optimum shelf life.The products should be stored in aluminum foil pouches that help to prevent the balloons from premature deterioration.These pouches should only be removed immediately prior to use.We have requested the customer to provide us with information on how these catheters were stored at the hospital.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 number.Therefore, we believe that it was an isolated incident.The malfunction was detected during the pre-use check.The surgeon used another catheter to complete the procedure.
Event or Problem Description
When the physician opened the packaging, the balloon had already ruptured in the tray.The surgeon then used another puritt aortic occlusion catheter to complete the procedure.

• Brand Name: PRUITT AORTIC OCCLUSION CATHETER
• Common Device Name: OCCLUDER, CATHETER TIP
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 15178197
• Report Number: 1220948-2022-00070
• Device Sequence Number: 5034579
• Product Code: DQT
• UDI-Device Identifier: 00840663101511
• UDI-Public: 00840663101511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K872090
• 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): 08/04/2022

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: 09/28/2022
• Device Model Number: 2100-12
• Device Catalogue Number: 2100-12
• Device Lot Number: PAO1185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2017
• 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