MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. DISTAL PERFUSION CATHETER

Catalog Number	2105-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation.The provided photo confirmed the report.It shows the balloon ruptured.The report stated that the balloon was found ruptured during the pre-use check.However, the provided photo of the device suggests that the product was used and may have ruptured during use, not during pre-use check.While the reported event was confirmed, the exact root cause of the balloon rupture could not be determined.The ifu lists the potential complications: as with all catheterization and surgical procedures, complications may occur.These may include, but are not limited to: embolization of blood clots, arteriosclerotic plaque or air.Hypertension or hypotension.Infection.Intimal disruption.Arterial dissection.Vessel perforation and rupture.Hemorrhage.Arterial thrombosis.Aneurysms.Arterial spasms.Local hematomas.Arteriovenous fistula formation.Balloon rupture.Tip separation with fragmentation and distal embolization.Paraplegia.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.
Event or Problem Description
It was reported that the distal perfusion catheter balloon was found ruptured.No injury was reported to the patient.

• Brand Name: DISTAL PERFUSION CATHETER
• Common Device Name: PERFUSION 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: 18545981
• Report Number: 1220948-2024-00020
• Device Sequence Number: 12993391
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: (01)00840663101610
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032041
• 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): 01/19/2024

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: 2105-15
• Device Lot Number: XDP1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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