MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PTCA DILATATION CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	MONORAIL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Broken catheter balloon.Fda safety report id # (b)(4).

• Brand Name: PTCA DILATATION CATHETER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 12210632
• Report Number: MW5102685
• Device Sequence Number: 1493501
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: (01)08714729846659
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 03/29/2023
• Device Model Number: MONORAIL
• Device Catalogue Number: REF H7493926720300
• Device Lot Number: 27053054
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR