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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 7314
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : the returned complaint device consisted of a nc emerge balloon catheter. The balloon is loosely folded. The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined. The hypotube is completely separated 89. 9cm from the hub. The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation. There are numerous hypotube and shaft kinks along the device. Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 27-jul-2020. It was reported that shaft kink occurred. The target lesion was located in the right coronary artery. A 4. 00mm x 20mm nc emerge balloon catheter was advanced for dilatation. However, during the insertion, the shaft kinked. The device was removed and the procedure was completed with another nc emerge balloon. There were no patient complications reported. However, returned device analysis revealed shaft detachment.
 
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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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10427048
MDR Text Key204877569
Report Number2134265-2020-10814
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUY
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 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/12/2020
Device Model Number7314
Device Catalogue Number7314
Device Lot Number0022504646
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2018
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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