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

Model Number	H7493926708300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of severe lad (left anterior descending artery) disease and recent chest pain.Procedure: left heart catheterization and percutaneous transluminal angioplasty with stent.The emerge balloon could not load onto the wire.A new emerge used without difficulty.No known harm to patient.Manufacturer response for catheters, transluminal coronary angioplasty, percutaneous, nc emerge (per site reporter).Will obtain.

• 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: 18020183
• Report Number: 18020183
• Device Sequence Number: 20467666
• Product Code: LOX
• UDI-Device Identifier: 08714729846260
• UDI-Public: (01)08714729846260(17)250731(10)32128700
• 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): 10/18/2023
• Report Date (Section F): 10/18/2023

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: H7493926708300
• Device Lot Number: 32128700
• 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: 10/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 86 KG
• Date Report Sent to FDA: 10/18/2023