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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 H7493912412300
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 09/06/2021
Event Type  malfunction  
Event Description
During an acute mi/percutaneous coronary intervention, the physician was advancing an nc quantum apex rx balloon and the shaft broke in two. The entire device was removed from the patient.
 
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Brand NameNC QUANTUM APEX
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12525458
MDR Text Key273103584
Report Number12525458
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493912412300
Device Catalogue NumberH7493912412300
Device Lot Number27038764
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2021
Event Location Hospital
Date Report to Manufacturer09/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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