MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC NC EMERGE NON-COMPLIANT BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	2.5MMX30MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Attempt pci of the native rca complicated by balloon rupture and retained balloon material in the mid rca.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC NC EMERGE NON-COMPLIANT BALLOON
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 13366944
• Report Number: MW5107012
• Device Sequence Number: 19373328
• Product Code: LOX
• UDI-Device Identifier: 08714729846765
• UDI-Public: (01)08714729846765(17)230825(10)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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: 08/05/2023
• Device Model Number: 2.5MMX30MM
• Device Catalogue Number: H7493926730250
• Device Lot Number: 27902036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White