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

Model Number	H7493918915350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Extravasation (1842); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)
Date of Event	01/24/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
G4 pma/510(k): k163174.
Event or Problem Description
It was reported that peroration and death occurred.On (b)(6) 2025, the patient presented with stable angina.The same day the patient underwent percutaneous coronary intervention using cutting balloon angioplasty in the proximal left anterior descending (lad).The lesion was predilated with a 15 mm x 3.00 mm wolverine coronary cutting balloon at the lad.Intravascular ultrasound (ivus) was performed, and additional dilatation was performed with a 3.50 mm x 15 mm emerge balloon and a 4.00 mm x 8 mm emerge balloon.An ellis class 3 perforation in the proximal lad occurred which was considered to have been caused by the 3.50 x 15mm emerge balloon.The perforation was covered initially with a 4.00 x 20 mm non-boston scientific (non-bsc) stent and pericardiocentesis performed.A 3.00 x 20 mm non-bsc stent was implanted distal to the initial cover stent in view of persistent extravasation.Cardiopulmonary resuscitation (cpr) was started due to profound hypotension.The patient was intubated, and veno-arterial extracorporeal membrane oxygenation (va ecmo) was inserted.The left main (lm) was re-engaged via the left femoral artery (lfa) using an 8fr non-bsc guiding catheter.It was seen that the perforation was sealed, and the first diagonal was lost but there was satisfactory ivus and angiographic result.Transesophageal echocardiography (tee) showed restriction and a calcified aortic valve.Balloon valvuloplasty was performed with a 20 mm non-bsc balloon.A reperfusion sheath 6fr was inserted to the right superficial femoral artery (sfa).The patient was on ecmo with low flows and chugging.The pericardial drain had been removed.There was concern for right-sided crepitus and a chest x ray was obtained.The patient had worsening pressor requirements status post 7 liters of intravenous fluid prompting transfusion of multiple blood products.The patient suffered a cardiac arrest and return of spontaneous circulation (rosc) was achieved after 1 round of cpr, epi and bicarb.Bedside cardiac ultrasound showed moderate pericardial effusion.The next day, the patient condition was further complicated by ecmo chugging and elevated central venous pressure (cvp).Additionally, the patient experienced an acute ischemic stroke of the left occipital and cerebellar lobes without thrombolysis or thrombectomy, and developed thrombocytopenia, leading to the discontinuation of heparin.On (b)(6) 2025, the patient subsequently underwent repeat pericardial drainage with pigtail placement and swan ganz insertion in catheterization lab.On (b)(6) 2025, the patient noted to have worsening pressor requirements, worsening lactate, worsening renal function, and developed sustained ventricular tachycardia.The patient was started on amiodarone.The patient was weaned off sedation with no neurologic response noted over course of 24 hours.On (b)(6) 2025, the patient was noted to be asystole on monitor.The ecmo circuit was clamped, and the ventilator stopped.The subject was pronounced as deceased.

• Brand Name: 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21449715
• Report Number: 2124215-2025-11060
• Device Sequence Number: 7939795
• Product Code: LOX
• UDI-Device Identifier: 08714729806257
• UDI-Public: 08714729806257
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220,
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: H7493918915350
• Device Catalogue Number: H7493918915350
• Device Lot Number: 0034299988
• 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: 02/03/2025
• Initial Report FDA Received Date: 02/24/2025
• Date Device Manufactured: 06/24/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Male