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

Model Number	M0062251220
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a nuromax ultra kit with encore 26 inflator was used in the kidney during a lithotripsy procedure performed on (b)(6) 2022.During the procedure, the protective sleeve of the balloon was difficult to remove.The procedure was completed with another nuromax ultra dilation balloon.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 shaft kinked.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable investigation result of shaft kinked.Investigation result: the uromax ultra balloon was returned together with the inflation device supplied in the kit, and a visual evaluation noted that the inflation device was returned in a sealed packaging which is an indication that the device was not used or attached to the balloon catheter.The device was returned with the balloon protector in place.Functional evaluation was performed by applying a vacuum to the device and the balloon protector was successfully removed from the device without problem.Additionally, it was observed that the balloon was not subjected to positive pressure.A visual and tactile examination found that the shaft of the device was kinked at more than one location.A visual examination of the balloon catheter found no problems with the balloon material, markerbands or tip of the device.No other problems with the device were noted.The reported event of difficult to remove protective sleeve was not confirmed.A labeling review was performed and from the information available, this device was not used per the instructions for use (ifu)/product label.Investigation found that the inflation device supplied with this uromax kit was returned unused and sealed inside its packaging.The ifu (instructions for use) instructs the user to attach an inflation device and apply a vacuum to the device.The vacuum must be maintained before removing the balloon protector.Failure to remove the air from the device most likely contributed to the resistance encountered when attempting to remove the balloon protector from the device.Additionally, the found problem of shaft kink is likely due to the interaction between the user and the device.Taking all available information into consideration, the most probable root cause is failure to follow instructions, since it was determined that the problems traced to the user not following the manufacturer's instructions.

• Brand Name: UROMAX ULTRA KIT
• 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: 16292662
• Report Number: 3005099803-2023-00178
• Device Sequence Number: 20471241
• Product Code: KOE
• UDI-Device Identifier: 08714729341291
• UDI-Public: 08714729341291
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K980795
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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: 10/26/2024
• Device Model Number: M0062251220
• Device Catalogue Number: 225-122
• Device Lot Number: 0028998669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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: Unknown