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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 7212
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2019
Event Type  malfunction  
Event Description
It was reported that shaft break occurred. The target lesion was located in mid left anterior descending artery. After a non-bsc guide catheter was placed, a 3. 25mm x 12mm nc emerge balloon catheter was advanced for dilatation. However, upon pulling the balloon out, the shaft broke in half. The procedure was completed with 3. 25x15mm non-bsc device. No patient complications were reported and the patient's status was fine.
 
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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 Key9532482
MDR Text Key177147199
Report Number2134265-2019-16199
Device Sequence Number1
Product Code LOX
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2021
Device Model Number7212
Device Catalogue Number7212
Device Lot Number0024395690
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 Received12/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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