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

Catalog Number	2105-15
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received both devices for evaluation.However, we were unable to confirm the reported defect with both devices.When the balloons in both devices were inflated to their maximum recommended volume of 3.4 ml, both balloons deflated normally by pulling the plunger of the syringe.All of the measurements in both devices were found to be within specification.Balloons in both catheters inflated symmetrically.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.Hence, we consider this to be an isolated incident.The procedure was completed using another distal perfusion catheter that they had in stock.
Event or Problem Description
During pre-use check, balloons of the two distal perfusion catheters (catalog # 2105-15, lot# dpc1115) failed to deflate completely.

• 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: 8204475
• Report Number: 1220948-2018-00114
• Device Sequence Number: 2792244
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1