MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. NOVASIL LATEX-FREE EMBOLECTOMY CATHETER

Catalog Number	1801-48
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the catheters back for evaluation since the devices have been discarded due to these devices being used in a hepatitis infected patient.However, we were able to confirm the reported incident for one device from the pictures of the defect provided to us.The proximal ligature was observed to have partially unwound.However, most of the proximal ligature were in proper position and were holding the balloon.The exact lot number of the catheters that were used in the procedure could not be determined.However, a review of batch records of the three most probable lot numbers (nse1942, nse1953, nse1947) that could have been used in the procedure did not reveal any discrepancies in the manufacturing process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from any of these lot numbers.At this time, we are inconclusive about the root cause of the defect.It is possible that the tension or the amount of glue applied during winding on this section of the ligature was not strong enough to prevent it from unwinding during the procedure.There was no injury or any impact on the patient's health as the result of this incident.
Event or Problem Description
The proximal ligature was found to have partially unwound during thrombectomy procedure in two of the novasil embolectomy catheters.

• Brand Name: NOVASIL LATEX-FREE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7877813
• Report Number: 1220948-2018-00067
• Device Sequence Number: 2365586
• Product Code: DXE
• UDI-Device Identifier: 00840663100927
• UDI-Public: 00840663100927
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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 Catalogue Number: 1801-48
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1