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

Model Number	H7493918915200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged male with history of cad (coronary artery disease) and positive stress test.Procedure: cardiac catheterization, angioplasty and stenting of lad (left anterior descending artery).While performing the angioplasty, the balloon ruptured.Device removed without known harm to patient and another balloon used successfully.Manufacturer response for catheters, transluminal coronary angioplasty, percutaneous, emerge (per site reporter): will obtain.

• Brand Name: 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: 17142977
• Report Number: 17142977
• Device Sequence Number: 7662852
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: (01)08714729806196(17)250905(10)30783976
• 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): 06/02/2023
• Report Date (Section F): 06/02/2023

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: H7493918915200
• Device Lot Number: 30783976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 133 KG
• Date Report Sent to FDA: 06/02/2023