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

Model Number	H7493926715300
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Mid 70¿s female with history of aortic stenosis, coronary artery disease and post cabg in 2001 and 2014.Procedure: heart cath, work up for transcatheter aortic valve replacement (tavr).Problem: balloon broke off the shaft causing coronary artery dissection and embolization.Balloon was left in vessel per physician decision.Monitored overnight and discharged home next day.Patient monitored for 1.5 hours post procedure in heart cath lab then overnight observation in the critical care unit.Echocardiogram to evaluate for left ventricular ejection fraction and regional wall motion- no changes.Anticipate tavr being done in 1 month.Per rep that examined the device "it broke after the black tip- proximal part of monovail" after watching the film stated "it appeared to break off when it was backed out".Manufacturer response for catheters, transluminal coronary angioplasty, percutaneous, nc emerge® (per site reporter).Per rep that examined the device "it broke after the black tip- proximal part of monovail" after watching the film stated "it appeared to break off when it was backed out".

• 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: 14521558
• Report Number: 14521558
• Device Sequence Number: 6428845
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: (01)08714729846529(17)H7493926715300(10)28906590
• 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): 05/20/2022
• Report Date (Section F): 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493926715300
• Device Lot Number: 28906590
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Female
• Patient Weight: 85 KG
• Date Report Sent to FDA: 05/20/2022