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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 7313
Device Problems Break (1069); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 09/08/2020
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 2.00mm x 15mm nc emerge balloon catheter was selected for use.However, when the device was taken out from the hoop, the proximal shaft was found to be kinked.When the device was returned to the bag, it got separated from the kinked area.The procedure was completed with a different device and no patient complications were reported.
 
Event Description
It was reported that shaft break occurred.A 2.00mm x 15mm nc emerge balloon catheter was selected for use.However, when the device was taken out from the hoop, the proximal shaft was found to be kinked.When the device was returned to the bag, it got separated from the kinked area.The procedure was completed with a different device and no patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 65.8cm distal of the strain relief.There was contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
 
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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 Key10606509
MDR Text Key209174572
Report Number2134265-2020-12882
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,distri
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/07/2022
Device Model Number7313
Device Catalogue Number7313
Device Lot Number0025497161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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