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

Model Number	M0062201090
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used during a transjugular liver biopsy procedure performed on (b)(6) 2023.During the procedure, it was noticed that the occluder balloon had a fly inside the packaging.It was reported that the box and the sterile packaging were both sealed with no sign of damage or tampering.It was deemed contaminated, and the procedure was completed with another occluder balloon catheter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign matter.
Additional Manufacturer Narrative
Block h6: imdrf device code a1802 captures the reportable event of foreign matter.Block h10: investigation result the returned occluder balloon device was analyzed, and no issues were found.A media analysis was performed and it was possible to observe a foreign matter and that the kit of the device was opened.With all the available information, boston scientific concludes that the reported event was confirmed.However, since the device kit was opened, it is not possible to determine the probable cause of the reported observation.Therefore, cause not established is selected as the most probable cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used during a transjugular liver biopsy procedure performed on (b)(6) 2023.During the procedure, it was noticed that the occluder balloon had a fly inside the packaging.It was reported that the box and the sterile packaging were both sealed with no sign of damage or tampering.It was deemed contaminated and the procedure was completed with another occluder balloon catheter.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 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: 17765868
• Report Number: 3005099803-2023-05022
• Device Sequence Number: 6768101
• Product Code: EYB
• UDI-Device Identifier: 08714729192008
• UDI-Public: 08714729192008
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 12/21/2023

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: 10/18/2024
• Device Model Number: M0062201090
• Device Catalogue Number: 220-109
• Device Lot Number: 0031653618
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: Unknown