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

Model Number	H7493926712300
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A patient with new onset of chest pain was admitted for a cardiac catheterization.While removing the monorail, the shaft broke on a nc emerge® ptca dilatation catheter with a balloon (3mm diameter and 12mm length).All pieces removed without known harm to the patient.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11929666
• Report Number: 11929666
• Device Sequence Number: 3237206
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: (01)08714729846390(17)221218(10)26540242
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/20/2021
• Report Date (Section F): 05/20/2021

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: No Information
• Device Model Number: H7493926712300
• Device Catalogue Number: H7493926712300
• Device Lot Number: 26540242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1
• Patient Weight: 74
• Date Report Sent to FDA: 05/20/2021