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

Model Number H7493926715300

Device Problem Break (1069)

Patient Problems Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)

Event Date 05/16/2022

Event Type  Injury  

Event 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®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14521558
• MDR Text Key: 292812157
• Report Number: 14521558
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: (01)08714729846529(17)H7493926715300(10)28906590
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 05/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 27010 DA
• Patient Sex: Female
• Patient Weight: 85 KG