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

Model Number	7311
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Loss of consciousness (2418)
Date of Event	03/02/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.The patient was presented with complaints of chest pain.An electrocardiogram (ecg) revealed diffuse st-segment depressions along with st elevations in the avr lead and a large myocardial infarction (mi was diagnosed.The patient was immediately transferred to the catheterization room for further evaluation and treatment.During coronary angiography, significant stenosis of the left main artery (lm) was identified, accompanied by heavy calcification in the distal segment of the artery, which complicated the intervention.Wires were advanced into the left anterior descending (lad) and left circumflex (lcx) arteries to facilitate treatment.Following this, balloon dilation was performed using a 2.5 nc emerge balloon catheter to open the narrowed arteries, after which a 4.5 x 15 non-boston scientific stent was implanted.However, further dilation with a 5.00mm x 8mm nc emerge balloon was necessary to expand the stent in a calcified area that did not open properly.Following dilatation, a significant perforation of the artery occurred, leading to blood extravasation into the pericardium.This resulted in an acute deterioration of the patient's condition, lost consciousness, and blood pressure dropped significantly, prompting the activation of a code blue.Despite immediate resuscitative efforts, including attempts to provide mechanical circulatory support via extracorporeal membrane oxygenation (ecmo)and intra-aortic balloon pump (iabp), these interventions failed due to the lack of access.The patients peripheral arteries were severely calcified, preventing effective access for the devices and eventually, the patient died.According to the hospital, the balloon length should have been 8mm, but the balloon measured length was16mm on film.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21690288
• Report Number: 2124215-2025-16925
• Device Sequence Number: 15620230
• Product Code: LOX
• UDI-Device Identifier: 08714729846321
• UDI-Public: 08714729846321
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 7311
• Device Catalogue Number: 7311
• 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: 03/04/2025
• Initial Report FDA Received Date: 03/25/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Female