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

Model Number	M0062251170
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 device was connected to a boston scientific encore inflation device and when positive pressure was applied, a liquid was observed to be leaking from a pinhole on the body of the balloon.No issues were noted on the markerbands, tip and the connectors of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.As there was no issue with the visual and functional test during product analysis, the complaint incident cannot be confirmed.The most probable root cause of the reported event therefore cannot be detected.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 dilation balloon catheter was used in the right ureter during an ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, it was noted that the luer lock of the balloon was broken.The procedure was completed with another uromax ultra dilation balloon catheter.There was no patient complications reported as a result of this event.Investigation results revealed that this balloon had a pinhole; therefore, this is now an mdr reportable event.

• 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: 11854563
• Report Number: 3005099803-2021-02371
• Device Sequence Number: 4016948
• Product Code: EZN
• UDI-Device Identifier: 08714729341253
• UDI-Public: 08714729341253
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 03/25/2023
• Device Model Number: M0062251170
• Device Catalogue Number: 225-117
• Device Lot Number: 0025404596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR