MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAXFORCE BALLOON DILATATION CATHETER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00567340
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While trying to dilate the pancreatic duct with maxforce biliary 4mm x 4cm balloon dilation catheter was noted the balloon had a hole.

• Brand Name: MAXFORCE BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16642960
• Report Number: 16642960
• Device Sequence Number: 17481084
• Product Code: FGE
• UDI-Device Identifier: 08714729097051
• UDI-Public: 08714729097051
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/22/2023
• Report Date (Section F): 03/22/2023

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: M00567340
• Device Lot Number: 28375034
• 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: 03/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White
• Date Report Sent to FDA: 03/22/2023