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

Model Number	6531
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.A 12mm x 4.00mm nc quantum apex balloon catheter was selected for used to dilate the lesion; however, it was noted that the balloon ripped off.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated, and the distal section of the device is missing.The missing parts are the distal inflation lumen, entire guidewire lumen, balloon, marker band, and tip.There are multiple kinks along the hypotube and on the core wire.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the distal section of the device is missing.
Event or Problem Description
It was reported that balloon detachment occurred.A 12mm x 4.00mm nc quantum apex balloon catheter was selected for used to dilate the lesion; however, it was noted that the balloon ripped off.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: 8182292
• Report Number: 2134265-2018-64513
• Device Sequence Number: 13850004
• Product Code: LOX
• UDI-Device Identifier: 08714729783305
• UDI-Public: 08714729783305
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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 Date: 10/12/2021
• Device Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0022788757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1