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

Model Number	6531
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of aware date as there was no date provided.
Event or Problem 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.
Event or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
(b3) date of event: updated date of event from (b)(6) 2020 to (b)(6) 2020.(b3) date of event: used the first day of the month of aware date as there was no date provided.

• 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: 9879890
• Report Number: 2134265-2020-03522
• Device Sequence Number: 14307462
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: 08714729783268
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,distri
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2020

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: 10/17/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024618058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/06/2020; 04/27/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/03/2020; 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: PROWATER; GUIDE WIRE: PROWATER; GUIDE WIRE: PROWATER