MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC REDDICK; CHOLANGIOGRAM CATHETER

Model Number	E2401-51
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was received through the fda report that was submitted by the user facility.Additional information has been requested along with the product to be returned with no response.There has been a total of (b)(4) sold of all lots since march 2018 with no additional complaints recorded for this occurrence.A follow up report will be submitted once we have received additional information.
Event or Problem Description
During a laparoscopic cholecystectomy with intraoperative cholangiogram.The cholangiogram catheter tip bubbled up at the end and could not be inserted.A new catheter had to be opened.
Additional Manufacturer Narrative
The product will not be returned for evaluation, as the part is contaminated and cannot be affectively cleaned for safe handling.There are no more boxes available of the same lot number for evaluation.This is the only complaint that has been received for this occurrence.As a result of this information, a true root cause could not be determined.This can be seen as the final report.If additional information is obtainled that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: REDDICK
• Common Device Name: CHOLANGIOGRAM CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 43 2nd avenue; burlington, ma
• MDR Report Key: 9695915
• Report Number: 3007208013-2020-00003
• Device Sequence Number: 3119081
• Product Code: GBZ
• UDI-Device Identifier: 00840663101818
• UDI-Public: 00840663101818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 10/28/2021
• Device Model Number: E2401-51
• Device Catalogue Number: E2401-51
• Device Lot Number: RST2649
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/12/2020
• Patient Sequence Number: 1