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

Model Number	7213
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Codes	Chest Pain (1776); Hematoma (1884); Foreign Body In Patient (2687); Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred resulting in patient complications.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal circumflex artery.The target lesion was wired and ballooned with an emerge but the lesion did not yield.A 3.0 x 15mm nc emerge balloon was then placed in the vessel and inflated to 24 atmospheres.The balloon ruptured on the second inflation and was stuck in the lesion, dissecting the vessel.The dissection was flow limiting and the patient experienced severe chest pain, hematoma, and thrombosis.When the physician attempted to remove the balloon, the shaft broke at the monorail transition.A buddy wire was used in an unsuccessful attempt to free the stuck balloon.The entire monorail and balloon were left in the patient and the procedure was ended.The patient was admitted and continues to be monitored.The patient had chest pain but was stable post procedure.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14579640
• Report Number: 2134265-2022-05858
• Device Sequence Number: 14905706
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• 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): 06/02/2022

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: 02/21/2024
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028906590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown