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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 7213
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2020
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred. The target lesion was fibrotic plaque within the left anterior descending artery. A 4. 00mm x 15mm nc emerge balloon catheter was advanced for post dilation. However, the balloon got stuck onto the wire and was not able to be removed without pulling out both devices together. After that, a new 4. 00mm x 8mm nc emerge balloon catheter and a non-bsc guidewire was placed, but after one inflation both devices got stuck also. And so both devices were removed. The procedure was completed with a placement of a new non-bsc wire into the vessel and ivus confirmed that the stent was well apposed. No patient complications were reported and the patient was stable.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9733566
MDR Text Key180613077
Report Number2134265-2020-01774
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/19/2021
Device Model Number7213
Device Catalogue Number7213
Device Lot Number0024962375
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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