MAUDE Adverse Event Report: BARD / C. R. BARD, INC. BARD PLATINUM CLASS II; FLAT WIRE STONE BASKET / DISLODGER, STONE, BASKET, URETERAL

Model Number	045370
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt underwent ureteroscopy with stone extraction procedure.The md used a basket to retrieve the stone.The operating room tech could not close the basket around stating it was stuck.The md was able to remove the basket, but the ureter was damaged in the process.

• Brand Name: BARD PLATINUM CLASS II
• Common Device Name: FLAT WIRE STONE BASKET / DISLODGER, STONE, BASKET, URETERAL
• Manufacturer (Section D): BARD / C. R. BARD, INC.; covington GA
• MDR Report Key: 7463900
• Report Number: MW5076735
• Device Sequence Number: 128050
• Product Code: FFL
• UDI-Device Identifier: 00801741066894
• UDI-Public: (01)00801741066894
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 09/30/2021
• Device Model Number: 045370
• Device Catalogue Number: 045370
• Device Lot Number: BMAWMM12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2018
• 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: Required Intervention