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

Model Number	M0064002111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2023.During the procedure, the catheter was being removed from the scope; however, the catheter broke.The physician reported that no unordinary resistance was felt and there was no any misuse.The procedure was completed with another flexima ureteral catheter.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2023.During the procedure, the catheter was being removed from the scope; however, the catheter broke.The physician reported that no unordinary resistance was felt and there was no any misuse.The procedure was completed with another flexima ureteral catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: additional information: block d7a (sud reprocessed and reused) and block h8 (usage of device) have been updated based on the additional information received on may 11, 2023.Block h6: imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2023.During the procedure, the catheter was being removed from the scope; however, the catheter broke.The physician reported that no unordinary resistance was felt and there was no any misuse.The procedure was completed with another flexima ureteral catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Block h10: investigation results: the returned flexima ureteral catheters were analyzed and a visual examination found that the catheter shaft was detached.The tip and connector cap were in good condition.A microscopic inspection of the catheter confirmed the catheter shaft was detached.Functional analysis was performed, and a mandrel of 0.036" was used and passed through the stent without resistance.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of catheter break was confirmed as the catheter shaft was detached on the returned device.It is possible that factors encountered during the procedure such as some operational factors and the interaction of the excess force during interaction with the device and/or with another device such as some tension applied over the device could cause the detachment of the catheter shaft.These factors and interactions could influence the damage found in the returned device.Therefore, the most probable root cause is adverse event related to procedure.

• Brand Name: URETERAL 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: 16895861
• Report Number: 3005099803-2023-02487
• Device Sequence Number: 20414636
• Product Code: GBM
• UDI-Device Identifier: 08714729342168
• UDI-Public: 08714729342168
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K870694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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: 10/12/2025
• Device Model Number: M0064002111
• Device Catalogue Number: 400-211
• Device Lot Number: 0030335834
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 06/14/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/07/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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