MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was used in the bladder and ureter during ureteroscopy (urs) procedure performed on (b)(6)2020.According to the complainant, during the procedure, it was noted that the catheter was broken into two pieces while passing the device.Reportedly, the device was retrieved.The procedure was completed with another flexima ureteral catheter.There were no patient complications reported as a result of this event.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10850897
• Report Number: 3005099803-2020-05392
• Device Sequence Number: 14058241
• Product Code: GBM
• UDI-Device Identifier: 08714729342083
• UDI-Public: 08714729342083
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K870694
• 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): 11/17/2020

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: 05/27/2023
• Device Model Number: M0064002011
• Device Catalogue Number: 400-201
• Device Lot Number: 0025541746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/17/2020
• 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