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

Model Number	M0062201090
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, the device was inserted in the ureter and the physician filled in the balloon; however, the balloon burst when inflated to 11 atm.It was reported that the device was removed from the patient, and the procedure was completed without using an occluder balloon catheter.There were no patient complications reported as a result of this event.The patient outcome of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h6: medical device code a0402 captures the reportable event of balloon burst.Block h2: additional information (block h5) block h10: investigation result a visual examination of the returned device found that the catheter and the balloon has no damage.Functional examination was performed and the device was tested with water and it did not hold the pressure due to it has a hole in the balloon.Based on the available information, the hole found in the balloon is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical affairs.However, it is possible that interaction with any surface during the procedure could create friction on the balloon, causing the problem of hole during the procedure.Therefore, the most probable root cause is adverse event related to procedure.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 an occluder balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2022.During the procedure, the device was inserted in the ureter and the physician filled in the balloon; however, the balloon burst when inflated to 11 atm.It was reported that the device was removed from the patient, and the procedure was completed without using an occluder balloon catheter.There were no patient complications reported as a result of this event.The patient outcome of the procedure was reported to be fully recovered.Additional information received on october 21, 2022: it was reported that the balloon burst when inflated to 11.3mm.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15649519
• Report Number: 3005099803-2022-05918
• Device Sequence Number: 5966620
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 09/29/2023
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0029312960
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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: Unknown