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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 Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 3.50mm x 20mm nc emerge balloon catheter was advanced for post-dilatation.However, during third inflation at 17 atmospheres for 16-18 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
 
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 contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.There were two longitudinal tears.One tear 9mm long starting mm distal of the distal marker band and one 8mm long starting 2mm distal of the distal marker band.
 
Event Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 3.50mm x 20mm nc emerge balloon catheter was advanced for post-dilatation.However, during third inflation at 17 atmospheres for 16-18 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.
 
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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 Key11023967
MDR Text Key222023812
Report Number2134265-2020-18038
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 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/04/2022
Device Model Number7314
Device Catalogue Number7314
Device Lot Number0026299061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Date Manufacturer Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
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