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

Model Number	M0062251180
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a uromax ultra balloon dilatation catheter was used in the right ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2022.During the procedure, it was noticed that there was an obstruction in the middle of the catheter and the guidewire would not enter.The procedure was completed with another uromax ultra balloon dilatation catheter.Note: a photo was submitted by the customer showing that the catheter was kinked at the middle section.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 a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: medical device code a0406 captures the reportable event of catheter kinked.Block h10: investigation result: a visual examination of the returned complaint device found that they were unable to load the device onto a boston scientific guidewire.The guidewire used by customer was not returned for analysis.Visual examination was performed to the shaft of the device and was severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual examination was performed to the balloon, markerbands and the tip and no issues or damage were found of the returned device.Additionally, the balloon had not been inflated.The reported problem is most likely due to excessive force being applied when handling the device during preparation for the procedure.The kinking to the shaft would have prevented the device from being loaded on to a guidewire during the event.Therefore, the most probable root cause is unintended use error caused or contributed to event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the 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 dilatation catheter was used in the right ureter during a ureteroscopy (urs) procedure performed on (b)(6) 2022.During the procedure, it was noticed that there was an obstruction in the middle of the catheter and the guidewire would not enter.The procedure was completed with another uromax ultra balloon dilatation catheter.Note: a photo was submitted by the customer showing that the catheter was kinked at the middle section.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.

• 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: 15672540
• Report Number: 3005099803-2022-06034
• Device Sequence Number: 6369236
• Product Code: KOE
• UDI-Device Identifier: 08714729341260
• UDI-Public: 08714729341260
• 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): 11/29/2022

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: 08/10/2024
• Device Model Number: M0062251180
• Device Catalogue Number: 225-118
• Device Lot Number: 0027819304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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