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 Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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
This report pertains to one of three axxcess ureteral catheter open end used during the same procedure.It was reported to boston scientific corporation that three axxcess ureteral catheter open end were used during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, three ureteral catheters broke consequently during the procedure.Reportedly, no piece of the devices detached inside the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1069 captures the reportable event of catheter break.Block h10: investigation results.A visual examination of the returned complaint device confirmed that the catheter was broken.Marks around the broken area was also noted which suggest interaction with an unknown device.The residues inside the catheter indicates the use and handling of the device.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
This report pertains to one of three axxcess ureteral catheter open end used during the same procedure.It was reported to boston scientific corporation that three axxcess ureteral catheter open end were used during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, three ureteral catheters broke consequently during the procedure.Reportedly, no piece of the devices detached inside 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: 8483004
• Report Number: 3005099803-2019-01593
• Device Sequence Number: 1921708
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 02/01/2023
• Device Model Number: M0064001161
• Device Catalogue Number: 400-116
• Device Lot Number: 0023285073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1