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

Catalog Number	2105-15
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/14/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We found that the tyvek lid was already separated on three sides of the tray in which the catheter was contained.Since we observed uniform seal marks on the entire border of the tray, we could confirm that this device was properly sealed during manufacturing.However, at some stage, the tyvek lid was physically removed.We could not confirm if the tyvek lid was removed at the user facility or at some other locations.However, the defect is clearly visible and cannot go undetected.All manufacturing and qc steps were completed in accordance to manufacturing instructions.Further, we have not received any other complaints of a similar nature for devices from this lot.This device did not come in contact with patient and was not used for the procedure.
Event or Problem Description
User received an unsealed tray of a lemaitre perfusion catheter.She observed the tyvek lid was already separated at three sides of the tray when it was removed from its outer package.This device did not come in contact with patient and was not used for the procedure.

• Brand Name: LEMAITRE DISTAL PERFUSION CATHETER
• Common Device Name: DISTAL PERFUSION CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 9469474
• Report Number: 1220948-2019-00165
• Device Sequence Number: 2474596
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 00840663101610
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K032041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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: 10/28/2022
• Device Catalogue Number: 2105-15
• Device Lot Number: DPC1109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1