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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. The device was removed from the guidezilla ii. Visual examination revealed that the balloon is separated 1cm from the tip. There are multiple kinks along the hypotube. Microscopic examination revealed that the guidewire lumen is stretched from the tip to 9cm from the tip. There is multiple buckling in the stretched area. The guidewire was attempted to be removed but it appears to be stuck because of the damages so it was left in place. Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 19dec2019. A 12mmx3. 50mm nc quantum apex was returned with no reported issues. However, device analysis revealed balloon separation.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9575964
MDR Text Key178011244
Report Number2134265-2019-16572
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 01/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6531
Device Catalogue Number6531
Device Lot Number0024164251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2019
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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