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

Model Number	M0064002011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was used in the urinary bladder during a cystoscopy with retrograde pyelogram procedure performed on (b)(6) 2017.According to the complainant, during the procedure, a part of the catheter was broken into pieces and was dislodged in the catheter.The broken pieces was irrigated out of the bladder.There were no reported complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6568867
• Report Number: 3005099803-2017-01500
• Device Sequence Number: 13679303
• Product Code: GBM
• UDI-Device Identifier: 08714729342083
• UDI-Public: (01)08714729342083(17)20200131(10)20177548
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: M0064002011
• Device Catalogue Number: 400-201
• Device Lot Number: 20177548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/16/2017
• 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