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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 7312
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, when the device was advanced over the wire, the shaft kinked.The physician attempted to straighten the shaft again but it broke into two parts.This occurred outside the patient and the physician was able to retrieve both parts.The procedure was completed with another 3.00mm x 12mm nc emerge balloon catheter.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube and the hypotube is separated 78.8cm from the hub.Microscopic examination revealed no additional damages.There is contrast present in the hub and blood on the balloon folds.The balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, when the device was advanced over the wire, the shaft kinked.The physician attempted to straighten the shaft again but it broke into two parts.This occurred outside the patient and the physician was able to retrieve both parts.The procedure was completed with another 3.00mm x 12mm nc emerge balloon catheter.No patient complications were reported.
 
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Brand Name
NC EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8178479
MDR Text Key130795828
Report Number2134265-2018-64354
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/29/2020
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0022862745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2019
Date Manufacturer Received01/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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