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

Model Number 7213

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546)

Patient Problems Chest Pain (1776); Hematoma (1884); Foreign Body In Patient (2687); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 05/16/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 293253612
• Report Number: 2134265-2022-05858
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization