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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 H7493927608600
Device Problem Incorrect Measurement (1383)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that the balloon length was incorrect. The target lesion was located in the proximal left anterior descending artery. A 6. 00mm x 8mm nc emerge® balloon catheter was advanced for dilatation and when the balloon was inflated at 6 atmospheres, the physician thought that there was an issue with the markers and that the balloon was longer than 8mm. The balloon ended up in the left main due to the excessive length. There were no patient complications.
 
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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 Key7007083
MDR Text Key92490203
Report Number2134265-2017-10959
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
SIMILAR
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 10/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model NumberH7493927608600
Device Catalogue Number39276-0860
Device Lot Number20028305
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 Received10/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2016
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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