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

Model Number MONORAIL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  malfunction  

Event Description

Broken catheter balloon.Fda safety report id # (b)(4).

• Brand Name: PTCA DILATATION CATHETER
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 12210632
• MDR Text Key: 263123758
• Report Number: MW5102685
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: (01)08714729846659
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR