MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3 CAROTID SHUNT

Catalog Number	2013-10
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pruitt f3 carotid shunt blue cap balloon ruptured during testing on 3 products.It was not directly used on the patient.No injury was reported to the patient.Note: this is report 1 of 3 related to the first shunt used in the event.Reports 1220948-2024-00174 and 1220948-2024-00175 were submitted for the second and third devices involved in this event.
Additional Manufacturer Narrative
The unused device was received for investigation.The surface of the balloons appeared abnormal.Holes/damage appeared on the surface of the balloons which prevented them from inflating as intended.While the reported damaged balloons were confirmed, the exact cause of the damage/abnormal balloons could not be determined.It is possible that the products were exposed to abnormal storage conditions or were damaged while preparing the devices for the procedure.Additionally, the balloons/glue holding the balloons appeared to have a yellow tint to them.Communication with the site indicated that this was due to the use of an iodine tincture while preparing the patient for surgery.While the iodine contributed to the yellow coloring observed, we do not believe that it would cause/contribute to the damaged balloons.The ifu provides the following warnings related to storage of the product: avoid extended or excessive exposure to fluorescent light, heat, sunlight, or chemical fumes to reduce balloon degradation.Excessive handling during insertion, and/or plaque and other deposits within the blood vessel, may damage the balloon and increase the possibility of balloon rupture.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.Note: this is report 1 of 3 related to the first shunt used in the event.Reports 1220948-2024-00174 and 1220948-2024-00175 were submitted for the second and third devices involved in this event.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CAROTID SHUNT
• 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: 20310091
• Report Number: 1220948-2024-00173
• Device Sequence Number: 18352319
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252(11)210106(17)251228(10)QPF1013(91)2013-10
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K182916
• 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): 09/26/2024

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 Expiration Date: 12/28/2025
• Device Catalogue Number: 2013-10
• Device Lot Number: QPF1013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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