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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 6532
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
 
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.When the box of a 15mm x 2.75mm nc quantum apex balloon catheter was opened, it was noted that the device was broke into two fragments.The procedure was completed with another device.There were no patient complications reported and the patient status was stable.
 
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Brand Name
NC QUANTUM APEX
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9335964
Report Number2134265-2019-13954
Device Sequence Number13915627
Product Code LOX
UDI-Device Identifier08714729783367
UDI-Public08714729783367
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K121667
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/12/2022
Device Model Number6532
Device Catalogue Number6532
Device Lot Number0023339168
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/04/2019
Initial Report FDA Received Date11/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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