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	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation since the complaint unit was discarded by the user.Hence, we could not conclusively determine the root cause of the malfunction.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.All of the 199 units of distal perfusion catheters that were manufactured in this lot number have been sold.We have not received any other complaints of a similar nature for devices from this lot.Therefore, we believe that it was an isolated incident.The malfunction occurred during the pre-use check.The surgeon used another distal perfusion catheter to complete the procedure.
Event or Problem Description
During pre-use check, when surgeon attempted to inflate the balloon, it ruptured.So, he used another catheter for the procedure.

• 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: 11828748
• Report Number: 1220948-2021-00047
• Device Sequence Number: 17091215
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 03/04/2020
• Device Model Number: 2105-15
• Device Catalogue Number: 2105-15
• Device Lot Number: DPC1148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1