MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

Model Number	M0062201100
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device problem code a0402 captures the reportable investigation result of balloon ruptured.Block h10: investigation results a visual examination of the returned complaint device found that the balloon was ruptured, this condition caused the balloon to become unable to be inflated.No additional damages were observed.Based on the available information, it is possible that operational factors, such as excess of force applied over the device, manipulation, interaction with other device/tool during its use could have caused the observed damage on the balloon, consequently affecting the overall performance of the balloon and its integrity.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used in the ureter during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, the occluder balloon was inserted in the kidney; however, when they went to inflate the balloon, there was no effect.They tried to inflate again but still the balloon did not inflate.The procedure was completed with another occluder balloon catheter.This event has been deemed a reportable event based on the investigation finding of balloon was ruptured.Please see device analysis results for full investigation details.There were no patient complications reported as a result of this event.

• Brand Name: OCCLUDER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18060565
• Report Number: 3005099803-2023-05868
• Device Sequence Number: 7729845
• Product Code: EYB
• UDI-Device Identifier: 08714729161691
• UDI-Public: 08714729161691
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K133750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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 Model Number: M0062201100
• Device Catalogue Number: 220-110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 45 YR
• Patient Sex: Male