MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN EXTRACTION BALLOON V; CATHETER, BILIARY, DIAGNOSTIC

Model Number	B-V233P-A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Inserted extraction balloon to sweep bile duct and balloon did not work, it had a hole upon inflation.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 w park dr; westborough MA 01581
• MDR Report Key: 20609518
• Report Number: 20609518
• Device Sequence Number: 7346513
• Product Code: FGE
• UDI-Device Identifier: 04953170368707
• UDI-Public: (01)04953170368707(17)270131(10)42V
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2024
• Report Date (Section F): 09/16/2024

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 Model Number: B-V233P-A
• Device Catalogue Number: N5384540
• Device Lot Number: 42V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 09/16/2024