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

Catalog Number 2105-15

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 333276592
• Report Number: 1220948-2024-00020
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: (01)00840663101610
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K032041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 2105-15
• Device Lot Number: XDP1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1