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

Model Number	6533
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
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 multiple minor kinks along the hypotube.Microscopic examination revealed that the guidewire lumen is buckled 47mm from the tip and is approximately 2mm long.There is a hole in the guidewire lumen in the buckled section approximately 48mm from the tip.The balloon is still tightly folded.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.A.014 in test guide wire was advanced into the guide wire lumen and was unable to pass the buckled section.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 04-jan-2019.It was reported that loading difficulties were encountered.The target lesion was located in a coronary artery.A 20mm x 3.50mm nc quantum apex and a 2.50mm x 12mm emerge balloon catheters were selected for use; however, both devices could not be loaded over the wire.The procedure was completed with a non-bsc device.No patient complications were reported since the devices did not enter the patient's body.However, returned device analysis revealed hole in shaft material.

• 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: 8273668
• Report Number: 2134265-2019-00276
• Device Sequence Number: 1448801
• Product Code: LOX
• UDI-Device Identifier: 08714729783503
• UDI-Public: 08714729783503
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2021
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0022934855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1