MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UROMAX ULTRA; DILATOR, CATHETER, URETERAL

Model Number	M0062251020
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Investigation result: a visual examination of the returned complaint device found that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit, and when positive pressure was applied the liquid was observed to be leaking from a balloon pinhole located at the proximal markerband.Additionally, the balloon pinhole was found to be located approximately in the same location as the shaft kink.The shaft of the device was kinked and there was no issue with the tip of the device.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue or design issue which could have caused the complaint and there is no evidence that the device failed.Therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon catheter was used in the ureter during a ureteroscopy procedure on an unknown date.During preparation, it was noticed that the balloon had a hole.The procedure was completed with another uromax ultra balloon catheter.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12459176
• Report Number: 3005099803-2021-04726
• Device Sequence Number: 11779025
• Product Code: EZN
• UDI-Device Identifier: 08714729341123
• UDI-Public: 08714729341123
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K130804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 01/08/2024
• Device Model Number: M0062251020
• Device Catalogue Number: 225-102
• Device Lot Number: 0026601009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1