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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493926715350
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 09/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: the device was not received for analysis. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
 
Event Description
It was reported that shaft break occurred. A 3. 50mmx15mm nc emerge® balloon catheter was selected for dilation. However, during preparation, when device was taken out of the hoop, it was noticed that that the shaft was severely kinked and the hypotube broke in halves. The device was never used into the patient's body. The procedure was completed with a different device. No patient complications were reported.
 
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Brand NameNC EMERGE®
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6944570
MDR Text Key90185861
Report Number2134265-2017-09932
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
Type of Report Initial
Report Date 09/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/24/2019
Device Model NumberH7493926715350
Device Catalogue Number39267-1535
Device Lot Number20921954
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 Received09/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2017
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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