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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
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.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, 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 Key14579640
MDR Text Key293253612
Report Number2134265-2022-05858
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729846529
UDI-Public08714729846529
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
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 Received06/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0028906590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/02/2022 Patient Sequence Number: 1
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