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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 7311
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2018
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a nc emerge device. The device was loosely folded, with blood in the inflation lumen and the hub of the device. Inspection revealed numerous kinks in the hypotube, and a pinhole in the balloon material located over the distal markerband. Inspection of the remainder of the device found no other damage or irregularities. Functional testing was conducted by attaching an inflation device filled with water to the hub of the complaint device and positive pressure was applied. When pressure was applied, water was found to be leaking out from a pinhole in the balloon material, and pressure could not be maintained.
 
Event Description
Reportable based on device analysis completed on 21-dec-2018. It was reported that inflation failure occurred. The target lesion was located in a coronary artery. A 5. 00mm x 8mm nc emerge balloon catheter was advanced for dilatation. However, when inflation was performed, it was unable to inflate. The device was completely removed from the patient and the procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed a pinhole in the balloon material.
 
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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 Key8248017
MDR Text Key133069880
Report Number2134265-2018-65105
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 01/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/27/2019
Device Model Number7311
Device Catalogue Number7311
Device Lot Number0021432824
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2017
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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