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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 7212
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2020
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation; however, the device snapped upon going in.The procedure was completed with a 2.5 x 15 non-bsc nc balloon catheter.No known patient complications were reported.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation; however, the device snapped upon going in.The procedure was completed with a 2.5 x 15 non-bsc nc balloon catheter.No known patient complications were reported.
 
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 22.9cm 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.Product analysis confirmed the reported broken shaft as the hypotube was separated.
 
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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 Key10184603
MDR Text Key196101211
Report Number2134265-2020-07440
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729846376
UDI-Public08714729846376
Combination Product (y/n)N
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/24/2022
Device Model Number7212
Device Catalogue Number7212
Device Lot Number0025397462
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2020
Date Manufacturer Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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