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

Model Number	6531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 12mm x 2.25mm nc quantum apex balloon catheter was used, however the shaft broke.No patient complications were reported.

• 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 Key: 10195980
• Report Number: 2134265-2020-07798
• Device Sequence Number: 3053324
• Product Code: LOX
• UDI-Device Identifier: 08714729783237
• UDI-Public: 08714729783237
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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 Date: 03/12/2023
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0025346559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1