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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 Problem Material Rupture (1546)
Patient Problem Vascular Dissection (3160)
Event Date 02/20/2019
Event Type  Injury  
Event Description
It was reported that balloon rupture and vessel dissection occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.It was then resulted to a breach of the coronary and intervention was done by the implantation of covered stents.The procedure was completed with a different device.
 
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.Microscopic examination revealed a longitudinal tear on the inflation lumen 31mm from the tip and is approximately 8mm long.The inflation lumen has a twist by the exit notch approximately 23.5cm from the tip.The balloon is pulled over the tip.There is contrast present in the inflation lumen and balloon.There is blood present in the balloon and hub.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that balloon rupture and vessel dissection occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.It was then resulted to a breach of the coronary and intervention was done by the implantation of covered stents.The procedure was completed with a different device.
 
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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 Key8449688
MDR Text Key139759890
Report Number2134265-2019-02874
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 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/12/2020
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0023077351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2019
Date Manufacturer Received04/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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