MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER OPEN END URETERAL AXXCESS¿ CATHETER; CATHETER, URETHRAL

Model Number	M0064001161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
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 an axxcess ureteral catheter was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the catheter broke into two pieces inside the patient but were successfully retrieved; however, it is unknown how the pieces were retrieved.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.
Additional Manufacturer Narrative
Fda# 4200820000-2017-8038.
Event or Problem Description
It was reported to boston scientific corporation that an axxcess ureteral catheter was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the catheter broke into two pieces inside the patient but were successfully retrieved; however, it is unknown how the pieces were retrieved.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be fine.Additional information received on november 07, 2017.The procedure was cysto, right ureteroscopy, retrograde.

• Brand Name: OPEN END URETERAL AXXCESS¿ CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6991144
• Report Number: 3005099803-2017-03262
• Device Sequence Number: 488395
• Product Code: GBM
• UDI-Device Identifier: 08714729191971
• UDI-Public: 08714729191971
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 10/12/2017

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: 08/14/2021
• Device Model Number: M0064001161
• Device Catalogue Number: 400-116
• Device Lot Number: 0021013182
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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
• Patient Age: 35 YR
• Patient Weight: 83