MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. POLYURETHANE DUAL LUMEN OCCLUSION CATHETER; CATHETER TIP OCCLUDER

Catalog Number	5F-2L-80
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed the balloon of the catheter had ruptured.No other defects were noted in this device.Device was used for removing for a clot which contradicts with the intended use of this device.This polyurethane dual lumen catheter is indented for temporarily occluding vessels during surgery.The root cause of the balloon failure is determined to be an user error.The arterial occlusion catheter should not be used for the removal of emboli/thrombi since this catheter is not designed to withstand the additional pull force needed to remove these materials.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.There was no injury to the patient as the result of this incident.
Event or Problem Description
During declotting, the balloon of the dual lumen occlusion catheter ruptured when it was pulled out of the arterial site.There was no injury to the patient as the result of the incident.

• Brand Name: POLYURETHANE DUAL LUMEN OCCLUSION CATHETER
• Common Device Name: CATHETER TIP OCCLUDER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 9512435
• Report Number: 1220948-2019-00173
• Device Sequence Number: 388613
• Product Code: DQT
• UDI-Device Identifier: 00840663102273
• UDI-Public: 00840663102273
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K844918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2019
• Device Catalogue Number: 5F-2L-80
• Device Lot Number: IOC1075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1