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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 7214
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: date the incident occurred was estimate as 01-aug-2019 which is the first day of the month of the aware date.
 
Event Description
It was reported that shaft break and removal difficulties occurred. A 2. 50mm x 20mm nc emerge balloon catheter was advanced for dilation. However, during inflation at 24 atmospheres, the shaft broke. Removal difficulty was noted so an optical coherence tomography was performed to assess the situation. Finally, the wire and the balloon were completely removed by snaring. No patient complications were reported.
 
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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 Key8960176
MDR Text Key156441440
Report Number2134265-2019-10622
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/02/2021
Device Model Number7214
Device Catalogue Number7214
Device Lot Number0023584574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/04/2019 Patient Sequence Number: 1
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