MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SINGLE LUMEN EMBOLECTOMY CATHETER

Catalog Number	1601-38
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the device for evaluation.The device was used for ventriculostomy to treat a patient with an obstructive hydrocephalus.The device is not designed or intended for this procedure.As clearly stated in our ifu, the lemaitre single lumen embolectomy catheter is intended only for the removal of arterial emboli and thrombi.Our ifu is also available and provided to the customers in spanish.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 for devices from this lot.There was no injury to the patient as the result of this incident.Another catheter was used to complete the procedure.
Event or Problem Description
A (b)(6) years old male patient with obstructive hydrocephalus underwent ventriculostomy procedure using lemaitre embolectomy catheter catalog# 1601-38, lot# slc4326.The physician was unable to remove the catheter from the ventricle, and the catheter was damaged while removing it.So, another catheter was used to complete the procedure.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8162163
• Report Number: 1220948-2018-00105
• Device Sequence Number: 1606439
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2023
• Device Catalogue Number: 1601-38
• Device Lot Number: SLC4326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR