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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 Material Puncture/Hole (1504)
Patient Problem No Patient Involvement (2645)
Event Date 12/05/2018
Event Type  malfunction  
Event Description
It was reported that shaft hole occurred. During preparation of a 3. 00mm x 12mm nc emerge balloon catheter, it was noted that the catheter coming out of the hoop was kinked. The guide wire would not go in and stopped, kinked or had a hole in the side of the shaft before the monorail part. No patient complications nor injuries were reported.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8176850
MDR Text Key130794737
Report Number2134265-2018-64498
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729846390
UDI-Public08714729846390
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
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/22/2020
Device Model Number7212
Device Catalogue Number7212
Device Lot Number0022411783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2018
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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