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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/14/2020
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 3.75mm x 12mm nc emerge balloon catheter was selected for use.However, it was noted that the shaft was broke 20cm from the hub.The procedure was completed with a non-bsc device.There were no patient complications reported and the patient was stable.
 
Event Description
It was reported that shaft break occurred.A 3.75mm x 12mm nc emerge balloon catheter was selected for use.However, it was noted that the shaft was broke 20cm from the hub.The procedure was completed with a non-bsc device.There were no patient complications 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 a complete separation at 62.2cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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 Key10369176
MDR Text Key201771513
Report Number2134265-2020-09628
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 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/15/2021
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0024604075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Date Manufacturer Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age45 YR
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