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

Model Number	7133
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Codes	Air Embolism (1697); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name: affiliated longhua hospital shanghai university of traditional chinese medicine initial reporter phone (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred, necessitating additional intervention.Coronary angiography was performed on the patient.The 80% stenosed target lesion was located in the middle-left anterior descending (lad) artery.A 2.50mm x 15mm emerge balloon catheter was used to dilate the lesion at 12 atmospheres.Re-examination of the angiography revealed that there was no reflow in the lad and gas embolization was considered.During examination of the balloon, it was observed that the delivery shaft was leaking gas.The patient experienced a drop in blood pressure to 60/30 mmhg and severe chest pain was reported.Subsequently, intracoronary normal saline flushing and injection of tirofiban were administered.A stent was implanted after the patient's condition improved and the procedure was successfully completed.

• 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: 19684692
• Report Number: 2124215-2024-41061
• Device Sequence Number: 14256012
• Product Code: LOX
• UDI-Device Identifier: 08714729806219
• UDI-Public: 08714729806219
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2026
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0032052108
• 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: 06/15/2024
• Initial Report FDA Received Date: 07/05/2024
• 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: Required Intervention
• Patient Sex: Unknown