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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 H7493926712300
Device Problem Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 03/10/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter. The balloon was loosely folded. There was contrast in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 30 cm from the hub and 65 cm from the tip. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There was tip damage. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
 
Event Description
Reportable based on analysis completed on 21-apr-2017. It was reported that shaft kink occurred. A 3. 00mm x 12mm nc emerge® balloon catheter was selected for dilation. Outside of the patient's body, one of the technicians prepared the device and kinked its shaft. The procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed a hypotube break.
 
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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 Key6530745
MDR Text Key74047450
Report Number2134265-2017-04493
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 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberH7493926712300
Device Catalogue Number39267-1230
Device Lot Number20225841
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2017
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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