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

Model Number 2105-15

Device Problem Material Rupture (1546)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for investigation.When we inflated the balloon with saline, the balloon failed to inflate due to a pinhole in the balloon.The entire balloon was intact in the catheter without any signs of balloon fragmentation.Surgeon did not inspect the device prior to the procedure.Based on our investigation, it is possible that the balloon came in contact with calcified segment of the patient's vessel resulting in balloon rupture.We have sent a list of follow-up questions to the contact person at the hospital but we have not yet received a response.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.There was no harm to the patient as the result of this incident.Surgeon used another distal perfusion catheter to complete the procedure.

Event Description

During abdominal aneurysm repair, balloon of the distal perfusion catheter burst in the middle of the inflation.

• Brand Name: DISTAL PERFUSION CATHETER
• Type of Device: EMBOLECTOMY 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7212212266
• MDR Report Key: 11531961
• MDR Text Key: 245078426
• Report Number: 1220948-2021-00030
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

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
• Device Operator: Health Professional
• Device Model Number: 2105-15
• Device Catalogue Number: 2105-15
• Device Lot Number: DPC1147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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