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

Model Number	7214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Chest Pain (1776); Perforation (2001); Cardiac Tamponade (2226); Vascular Dissection (3160)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that perforation occurred, requiring additional intervention.The patient presented with coronary artery disease and in-stent restenosis and was undergoing percutaneous coronary intervention.The target lesion was located in the middle left anterior descending artery.A 3.00x20 nc emerge balloon catheter was used to pre-dilate non-boston scientific stents placed in 2006.A 3.00x48mm synergy xd drug-eluting stent was then deployed.Following post-dilatation with a 3.50mm x 20mm nc emerge balloon catheter, the physician recognized the patient pulse rhythm had changed.Upon injection, a perforation was observed in the target lesion.In the physician's opinion, the inflation caused plaque shift and ultimately perforated the artery.The patient then experienced tamponade, chest pain, and premature ventricular contractions.The physician placed a covered stent and tamped off with a 3.00x20 emerge balloon catheter.A pericardial tap was performed, and an echocardiogram was completed.The patient was currently stable and expected to recover.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19975483
• Report Number: 2124215-2024-47850
• Device Sequence Number: 8543558
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: 08714729846673
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2026
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0033315764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/13/2024
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT - 3.00X48MM SYNERGY XD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female