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

Catalog Number	E1601-48
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no injury to the patient as the result of this incident.Patient has been discharged from the hospital.The incident occured on (b)(6) 2016.Patient was stable throughout the procedure.We received the device and were able to confirm that the balloon was not attached to the catheter.We have reviewed our batch records for this lot and all manufacturing and qc steps were completed in accordance to our internal procedures.No issues were noted on the paperwork during the manufacturing and inspection steps.At this time it is unclear what definitively caused the balloon to detach but it could have been due to getting caught on the stent during the procedure.
Event or Problem Description
From the hospitals description of the incident, it appears as though a 4 french lemaitre embolectomy catheter was used to either occlude the aorta during the placement of an endovascular stent or to remove arterial emboli and thrombi.At some point during the procedure the surgeon noticed that the balloon was not attached to the catheter.The balloon was retrieved with no further issue.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETERS
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 5967708
• Report Number: 1220948-2016-00020
• Device Sequence Number: 19072292
• Product Code: DXE
• UDI-Device Identifier: 00840663100606
• UDI-Public: 00840663100606
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2016

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: Physician
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: E1601-48
• Device Lot Number: SLC3784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2016
• Initial Report FDA Received Date: 09/21/2016
• 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: Other