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

Model Number	M0062251080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was to be used during a ureteroscopy (urs) procedure performed on (b)(6) 2023.During preparation, the catheter was bent in the middle.The procedure was completed with another uromax ultra dilation balloon catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of catheter bent.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of catheter bent.Block h10: investigation result a visual examination of the returned complaint device found that the balloon was tightly folded which indicates that the device was not subjected to positive pressure.A visual examination was performed to the tip or markerbands and no issue were noted.A visual, tactile and microscopic analysis was performed, and the shaft of the device was kinked at proximately 410mm distal of the hub of the device.The reported problem is most likely due to excessive force being applied when handling the device during preparation for the procedure which could have possible affected the device performance and its intended purpose.Therefore, the most probable root cause is unintended use error caused or contributed to event.
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra dilation balloon catheter device was to be used during a ureteroscopy (urs) procedure performed on (b)(6) 2023.During preparation, the catheter was bent in the middle.The procedure was completed with another uromax ultra dilation balloon catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.The device was not return.

• Brand Name: UROMAX ULTRA
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17599279
• Report Number: 3005099803-2023-04547
• Device Sequence Number: 6712797
• Product Code: KOE
• UDI-Device Identifier: 08714729341185
• UDI-Public: 08714729341185
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 04/03/2025
• Device Model Number: M0062251080
• Device Catalogue Number: 225-108
• Device Lot Number: 0029159012
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: Male