MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER URETERAL CATHETER; CATHETER, UROLOGICAL

Model Number	M0064001530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: a visual examination of the complaint device revealed that the catheter was broken and was kinked approximately at 15.3cm from the broken end.The noted failure likely occurred due to physical impact or damage on the device as a result of mishandling; therefore, the most probable root cause is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an open end ureteral axxcess catheter was used in the lower urinary tract during a cystoscopy, r retrograde pyelogram and r flexible ureteropyeloscopy procedure performed on (b)(6) 2017.According to the complainant, the catheter was sheared upon the insertion of the guidewire.It was reported that the device did not reach the patient.The procedure was completed with another open end ureteral axxcess catheter device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the catheter was broken; therefore, this is now an mdr reportable event.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7285815
• Report Number: 3005099803-2018-00513
• Device Sequence Number: 11105747
• Product Code: KOD
• UDI-Device Identifier: 08714729005193
• UDI-Public: 08714729005193
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K870694
• 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
• Report Date (Section B): 01/17/2018

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: 01/31/2019
• Device Model Number: M0064001530
• Device Catalogue Number: 400-153
• Device Lot Number: 17572514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 63