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

Model Number	6531
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There were two circumferential tears 4mm and 5mm distal from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found circumferential tears and tip damage to the device.
Event or Problem Description
Reportable based on device analysis completed on 27mar2020.A 12mm x 2.50mm nc quantum apex balloon catheter was received with no issue reported.However, returned device analysis revealed balloon torn circumferential.

• 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: 9978469
• Report Number: 2134265-2020-04416
• Device Sequence Number: 19658935
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

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: 08/15/2022
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0024276680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1