MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPEN END URETERAL AXXCESS CATHETER; CATHETER, URETHRAL

Model Number	M0064001161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a axxcess ureteral catheter device was used during a cystoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the catheter was found to be broken at the end after it was withdrawn from the patient.There were no patient complications reported as a result of this event.

• Brand Name: OPEN END URETERAL AXXCESS CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9529774
• Report Number: 3005099803-2019-06280
• Device Sequence Number: 459490
• Product Code: GBM
• UDI-Device Identifier: 08714729191971
• UDI-Public: 08714729191971
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K830840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2019

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 Expiration Date: 09/17/2023
• Device Model Number: M0064001161
• Device Catalogue Number: 400-116
• Device Lot Number: 0024452215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1