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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 No Consequences Or Impact To Patient (2199)
Event Date 12/14/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in a calcified vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, the balloon ruptured during inflation.The device was replaced with a 2.50x15mm nc emerge.No patient complications were reported and the patient was stable.
 
Manufacturer Narrative
Describe event or problem updated.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in a calcified vessel.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, the balloon ruptured during inflation.The device was replaced with a 2.50x15mm nc emerge.No patient complications were reported and the patient was stable.It was further reported that the target lesion was 70% stenosed and was located in a moderately calcified vessel.The ruptured balloon was completely removed from the patient's body.
 
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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 Key9514199
MDR Text Key176778698
Report Number2134265-2019-16090
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 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/24/2021
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0024006382
Was Device Available for Evaluation? No
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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