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

Model Number	M0062251070
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a uromax ultra dilation balloon catheter device was used during a ureteroscopic lithotripsy (ursl) procedure.Reportedly, the balloon could not dilate.The procedure was completed with another of the same device with no patient complications.Analysis of the returned basket identified that a pinhole in the balloon material was found located approximately 2mm distal of the distal markerband.
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: device code a041001 captures the reportable investigation result of balloon pinhole.Block h11: investigation results.The returned uromax balloon device was analyzed, and a visual evaluation noted that the balloon was not folded which indicates that the device was subjected to positive pressure.It was also noted that a pinhole in the balloon material was found located approximately 2mm distal of the distal markerband.Additionally, the balloon could not be inflated due to the balloon pinhole and the rated burst pressure of this device was 20 atmospheres.A visual and tactile examination was performed on the shaft, tip or markerbands and no damages were found.A labeling review was performed and there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Based on the available information the pinhole in the balloon material most probably occurred due to an interaction between the balloon and a kidney stone during the procedure.It would not be possible to inflate the device due to the balloon pinhole during the procedure.Therefore, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20563701
• Report Number: 2124215-2024-67383
• Device Sequence Number: 20830266
• Product Code: KOE
• UDI-Device Identifier: 08714729341178
• UDI-Public: 08714729341178
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 10/29/2024

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: 09/05/2024
• Device Model Number: M0062251070
• Device Catalogue Number: 225-107
• Device Lot Number: 0027968712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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