MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER URETERAL CATHETER; CATHETER, URETHRAL

Model Number	M0064002111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a flexima 5f cone tip ureteral catheter was used during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the ureter was perforated when advancing the flexima 5f cone tip ureteral catheter.The cone tip was noted to be too sharp.It is unknown if there was additional intervention performed for the punctured ureter and how the procedure was completed.No patient complications have been reported as a result of this event.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6629317
• Report Number: 3005099803-2017-01621
• Device Sequence Number: 16414461
• Product Code: GBM
• UDI-Device Identifier: 08714729342168
• UDI-Public: (01)08714729342168(17)20200131(10)20165186
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K830840
• 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): 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: M0064002111
• Device Catalogue Number: 400-211
• Device Lot Number: 20165186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1