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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 Problem Material Rupture (1546)
Patient Problems Perforation (2001); Discomfort (2330)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture, perforation, and patient discomfort occurred. A percutaneous coronary intervention (pci) was performed on a moderately calcified right coronary artery (rca) 3. After the very calcified rca 1 and 2 were rotablated, a 3. 00mm x 15mm nc emerge balloon was advanced to the target lesion and was inflated one time for one second at 18 atmospheres, but the balloon burst, and a perforation occurred. Patient discomfort resulted from the perforation. The balloon was successfully removed from the patient and no fragments of the device remained inside the patient. A stent was the advanced and deployed to cover the perforation and complete the procedure. No further patient complications were reported in relation to this event.
 
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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 Key10979134
MDR Text Key220641256
Report Number2134265-2020-17209
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7213
Device Catalogue Number7213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/09/2020 Patient Sequence Number: 1
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