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

Model Number	M0062201090
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole.
Event or Problem Description
It was reported to boston scientific corporation that a occluder balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, it was noticed that the inflated balloon was not visible under a fluoroscopy and suspected to have been burst.However, once they proceed with the procedure, they check the balloon's condition, and it turned out to have a hole on it causing it to leak hence it got deflated.The procedure was completed with the same device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a occluder balloon catheter was used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2023.During the procedure, it was noticed that the inflated balloon was not visible under a fluoroscopy and suspected to have been burst.However, once they proceed with the procedure, they check the balloon's condition, and it turned out to have a hole on it causing it to leak hence it got deflated.The procedure was completed with the same device.There were no patient complications reported as a result of this event.Additional information received on october 24, 2023: it was reported that a occluder balloon catheter was used in the kidney.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem), block d7a (sud reprocessed and reused) and block h8 (usage of device) have been updated based on the additional information received on october 24, 2023.Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole.

• 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17957024
• Report Number: 3005099803-2023-05586
• Device Sequence Number: 17894347
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 11/14/2023

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: 01/29/2025
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0032120661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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: Female