MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. OVER-THE-WIRE EMBOLECTOMY CATHETER

Catalog Number	1651-84
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed that the balloon in this catheter had a circumferential rupture and was missing about 5 mm of its balloon piece at its middle region.No other defects were noted on this device.The nurse could not confirm the volume of saline that was used to inflate the balloon during the pre-use check.At this time, we could not conclusively determine the root cause of the incident.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.Please note that we do conduct 100% inspection on each device and test them for balloon functionality.Our quality control inspector had also performed a pull test on a sample of the catheters from this lot number during in-process inspection.All of these units passed the qc requirements and performed as intended when tested to their validated force.Device did not come in contact with the patient at any time during the procedure.Please note that we have also reported manufacturer's report# 1220948-2020-00001, 1220948-2020-00002 and 1220948-2020-00004 related to other three otw catheters malfunction that occurred during this same event.The balloon of the otw catheter related to manufacturer's report# 1220948-2020-00001 ruptured during thrombectomy while the balloons of otw catheters related to manufacturer's report# 1220948-2020-00002 and 1220948-2020-00004 ruptured during pre-use check.
Event or Problem Description
During pre-use check, the balloon of over-the-wire embolectomy catheter ruptured when the balloon was inflated with saline.Device was not used in the patient.This is report 3 fo 4.

• Brand Name: OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 9549068
• Report Number: 1220948-2020-00003
• Device Sequence Number: 14298159
• Product Code: DXE
• UDI-Device Identifier: 00840663100859
• UDI-Public: 00840663100859
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022145
• 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): 01/03/2020

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: 12/28/2020
• Device Catalogue Number: 1651-84
• Device Lot Number: OTW2987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1