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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 6531
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first day of the month of aware date as there was no date provided.
 
Event Description
It was reported that catheter entrapment and shaft break occurred. A 12mm x 3. 00mm nc quantum apex balloon catheter was used for dilatation. The device was attempted to be removed to wipe the wire down more; however, the device became stuck on the non-bsc wire and the shaft broke in half. Both devices were completely removed as a unit. The procedure was completed with another balloon. No patient complications were reported.
 
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Brand NameNC QUANTUM APEX
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 Key9879890
MDR Text Key185023443
Report Number2134265-2020-03522
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup
Report Date 05/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6531
Device Catalogue Number6531
Device Lot Number0024618058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2019
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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