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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 7310
Device Problem Nonstandard Device (1420)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2018
Event Type  malfunction  
Event Description
It was reported that balloon inflated beyond its marker bands.The target lesion was located in the left main artery.A 5.00mm x 6mm nc emerge balloon catheter was advanced for post dilatation.However, during inflation it was noted that the balloon inflated beyond the marker bands.The device was completely removed from the patient and the procedure was completed with a different balloon catheter.No patient complications were reported and the patient's status was stable.
 
Event Description
It was reported that balloon inflated beyond its marker bands.The target lesion was located in the left main artery.A 5.00mm x 6mm nc emerge balloon catheter was advanced for post dilatation.However, during inflation it was noted that the balloon inflated beyond the marker bands.The device was completely removed from the patient and the procedure was completed with a different balloon catheter.No patient complications were reported and the patient's status was stable.Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.Inspection of the device presented no damage or irregularities.The balloon has no damage and is a non compliant balloon.The pictures mentioned were reviewed and do not show the balloon.There was no evidence of any damage or irregularities contributing to the reported event.
 
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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 Key7794757
MDR Text Key117576165
Report Number2134265-2018-60144
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 09/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2020
Device Model Number7310
Device Catalogue Number7310
Device Lot Number0022178290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2018
Date Manufacturer Received08/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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