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

Model Number	2105-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
During abdominal aneurysm repair, balloon of the distal perfusion catheter burst in the middle of the inflation.

• Brand Name: DISTAL PERFUSION CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 11531961
• Report Number: 1220948-2021-00030
• Device Sequence Number: 20136564
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1