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

Model Number	7132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Asystole (4442)
Date of Event	05/29/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.Coronary angiography revealed diffuse lesions in the distal segment of the left circumflex artery (lcx) 70-80% stenosis.The proximal segment of the obtuse marginal branch had a 90% stenosis.Long lesions noted in the proximal and middle segments of the left anterior descending (lad) artery with stenosis of 20-30%.The proximal right coronary artery (rca) had a 30% stenosis, middle rca segment 50% stenosis and distal rca segment 50% stenosis.The patient was experiencing chest tightness after medication treatment.The first lesion treated with intervention was the obtuse marginal branch and the lcx.Non-boston scientific (bsc) guide catheter and guidewire were placed and a 2.0 x 12mm emerge balloon catheter was pre dilated in the proximal segment of the obtuse marginal branch at 12 atmospheres for 5 seconds.A recheck angiography showed contrast agent retention in the middle and distal part of lcx.The blood pressure of the patient dropped to 80/50mmhg, and heart rate was 80 beats per minute.Finger oxygen 98%.Immediately administered 20mg of dopamine intravenously and administered dopamine and norepinephrine via intravenous infusion to maintain blood pressure.A 15ml intravenous infusion of tirofiban administered in the coronary artery.Recheck angiography showed there was no reflow in the lad and lcx.Widespread coronary thrombosis formation was considered, intracoronary injection of 10000 u of urokinase, and sent non-bsc thrombus aspiration catheter to the lad for repeatedly suction.Emergency consultation from the anesthesia department was performed.The blood pressure of the patient continued to decrease, and monitoring showed a straight line on the electrocardiogram.Continuously performed chest compressions, adrenaline intravenous injection, and isoproterenol intravenous injection.Endotracheal intubation conducted by anesthesiology department, balloon assisted ventilation, repeated administration of adrenal injection, at the same time puncture of femoral artery, inserting intra-aortic balloon pump (iabp), puncture the femoral vein and insert a temporary pacemaker, pacing at 5v output and 80 beats per minute.Chest compressions and balloon assisted ventilation were continued and dopamine and norepinephrine maintenance, rescue continued for a few hours.Ultimately, the heartbeat and breathing of the patient had not recovered, invasive blood pressure could not be measured, finger oxygen could not be measured, bilateral pupil enlargement to fixed edge, electrocardiogram straight line and the patient was declared dead.It was further reported that the physician suspected an air leak at the connecting shaft.Additionally, there was no visible pinhole observed on the balloon.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the patient died.Coronary angiography revealed diffuse lesions in the distal segment of the left circumflex artery (lcx) 70-80% stenosis.The proximal segment of the obtuse marginal branch had a 90% stenosis.Long lesions noted in the proximal and middle segments of the left anterior descending (lad) artery with stenosis of 20-30%.The proximal right coronary artery (rca) had a 30% stenosis, middle rca segment 50% stenosis and distal rca segment 50% stenosis.The patient was experiencing chest tightness after medication treatment.The first lesion treated with intervention was the obtuse marginal branch and the lcx.Non-boston scientific (bsc) guide catheter and guidewire were placed and a 2.0 x 12mm emerge balloon catheter was pre dilated in the proximal segment of the obtuse marginal branch at 12 atmospheres for 5 seconds.A recheck angiography showed contrast agent retention in the middle and distal part of lcx.The blood pressure of the patient dropped to 80/50mmhg, and heart rate was 80 beats per minute.Finger oxygen 98%.Immediately administered 20mg of dopamine intravenously and administered dopamine and norepinephrine via intravenous infusion to maintain blood pressure.A 15ml intravenous infusion of tirofiban administered in the coronary artery.Recheck angiography showed there was no reflow in the lad and lcx.Widespread coronary thrombosis formation was considered, intracoronary injection of 10000 u of urokinase, and sent non-bsc thrombus aspiration catheter to the lad for repeatedly suction.Emergency consultation from the anesthesia department was performed.The blood pressure of the patient continued to decrease, and monitoring showed a straight line on the electrocardiogram.Continuously performed chest compressions, adrenaline intravenous injection, and isoproterenol intravenous injection.Endotracheal intubation conducted by anesthesiology department, balloon assisted ventilation, repeated administration of adrenal injection, at the same time puncture of femoral artery, inserting intra-aortic balloon pump (iabp), puncture the femoral vein and insert a temporary pacemaker, pacing at 5v output and 80 beats per minute.Chest compressions and balloon assisted ventilation were continued and dopamine and norepinephrine maintenance, rescue continued for a few hours.Ultimately, the heartbeat and breathing of the patient had not recovered, invasive blood pressure could not be measured, finger oxygen could not be measured, bilateral pupil enlargement to fixed edge, electrocardiogram straight line and the patient was declared dead.It was reported further that physician also complained that they thought air leakage at the connecting shaft and there was no visible pinhole on the balloon.
Additional Manufacturer Narrative
Medical review: media clips were received and reviewed by boston scientific medical safety.From the clinical events and angiograms provided, the patient suffered an inadvertent and large air embolism from the guide catheter.There was resultant almost global ischemia and cardiac arrest as a result.No evidence of any equipment failure and the proposal that an air leak from the balloon shaft could have been responsible is not plausible.E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).

• 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; 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: 19867621
• Report Number: 2124215-2024-42268
• Device Sequence Number: 18180273
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: 08714729806080
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 03/21/2026
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0032052056
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 08/04/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG