MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE DISTAL PERFUSION CATHETER; CARDIOPULMONARY BYPASS VASCULAR CATHETER

Catalog Number	2105-15
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for evaluation.However, we have confirmed the reported incident based on the picture of the balloon provided to us by the hospital.The balloon inflated on only side of the lumen.Our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality.Each of the balloons are inflated with air using a syringe and then inspected to ensure balloons inflate concentric.At this time, we could not conclusively determine the root cause of the defect.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.In fact, this is the first and only complaint we have received of this nature in the lifetime of this device.We have not seen any adverse or upward trend relating to this attribute.Hence, no corrective action is required at this time.
Event or Problem Description
During pre-use check, the balloon of the distal perfusion catheter inflated non-concentric.

• Brand Name: LEMAITRE DISTAL PERFUSION CATHETER
• Common Device Name: CARDIOPULMONARY BYPASS VASCULAR CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• MDR Report Key: 8488700
• Report Number: 1220948-2019-00038
• Device Sequence Number: 11254322
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 00840663101610
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K032041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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: 03/28/2023
• Device Catalogue Number: 2105-15
• Device Lot Number: DPC1115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1