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

Model Number	M0064051160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was approximated to (b)(6) 2022 based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an axxcess ureteral catheter open end device was used in the ureter during a ureteral stent implantation procedure performed on an unknown date.During unpacking, it was noticed that the catheter was broken near the hand base.The stent placement procedure was completed without using the access ureteral catheter.Note: the photo submitted by the customer confirmed that the catheter was broken near the handle base.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an axxcess ureteral catheter open end device was used in the ureter during a ureteral stent implantation procedure performed on an unknown date.During unpacking, it was noticed that the catheter was broken near the hand base.The stent placement procedure was completed without using the access ureteral catheter.Note: the photo submitted by the customer confirmed that the catheter was broken near the handle base.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: event date was approximated to 03/01/2022 based on the date the manufacturer became aware of the event.Block h6: medical device code a0401 captures the reportable event of catheter break.Block h10: investigation results the returned axxcess ureteral catheter open end device was analyzed, and a visual evaluation noted that the device was returned in an open pouch.It was also observed that the catheter was torn at the distal end.No other problems with the device were noted.Media analysis performed to the photo submitted by the customer revealed that the catheter was torn and was outside its original pouch.Based on the condition of the returned device, the reported event of catheter break was confirmed.It is possible that operational factors such as the force used when the catheter was pushed up with the pusher over the guidewire, and/or the excessive force applied to the device during used could have caused the catheter to break.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14228104
• Report Number: 3005099803-2022-02126
• Device Sequence Number: 13878291
• Product Code: GBM
• UDI-Device Identifier: 08714729134213
• UDI-Public: 08714729134213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 02/06/2026
• Device Model Number: M0064051160
• Device Catalogue Number: 405-116
• Device Lot Number: 0028818234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown