MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER; CATHETER, CHOLANGIOGRAPHY

Model Number	E2401-51
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The cholangiogram catheter tip bubbled up at the end and could not be inserted.A new catheter had to be opened.

• Brand Name: REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER
• Common Device Name: CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• MDR Report Key: 9568647
• Report Number: 9568647
• Device Sequence Number: 3388997
• Product Code: GBZ
• UDI-Device Identifier: 00840663101818
• UDI-Public: (01)00840663101818
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2019
• Report Date (Section F): 12/21/2019

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 Model Number: E2401-51
• Device Catalogue Number: E2401-51
• Device Lot Number: RST2649
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/21/2019