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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 7313
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 07/28/2020
Event Type  Injury  
Event Description
It was reported that a shaft break occurred. A 3. 50mm x 15mm nc emerge balloon was advanced to the target lesion, but a shaft break occurred. It was noted that the nc emerge balloon snapped off after getting lodged inside the right coronary artery (rca). Surgical intervention was performed to removed the broken piece of the device. No additional 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 Key10374877
MDR Text Key201911304
Report Number2134265-2020-10602
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0025576520
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 Received10/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2020
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: 08/06/2020 Patient Sequence Number: 1
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