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

Model Number	M0064001161
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, 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 during a procedure performed on (b)(6) 2022.During unpacking, it was found that the tip of the catheter was torn.The procedure was completed with another axxcess ureteral catheter open end device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a0414 captures the reportable event of catheter tip was torn.Block h10: investigation result the returned axxcess ureteral catheter open end device was analyzed, and a visual evaluation noted that the distal end of the catheter was torn, thereby confirming the reported event.Functional evaluation was performed and a mandrel was inserted through the device and no resistance was felt.Microscopic inspection confirmed that the distal end of the catheter was torn.This problem is likely due to factors or conditions related to procedure, such as excessive force applied to the device when the catheter was pushed with the pusher over the guidewire or when the catheter was used which could have affected the device performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an axxcess ureteral catheter open end device was used during a procedure performed on (b)(6) 2022.During unpacking, it was found that the tip of the catheter was torn.The procedure was completed with another axxcess ureteral catheter open end device.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
• 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: 13423439
• Report Number: 3005099803-2022-00472
• Device Sequence Number: 5328038
• Product Code: GBM
• UDI-Device Identifier: 08714729191971
• UDI-Public: 08714729191971
• 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): 03/17/2022

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: 07/13/2025
• Device Model Number: M0064001161
• Device Catalogue Number: 400-116
• Device Lot Number: 0027667399
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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