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

Model Number	6534
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as event date since it was not provided.Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter.The device was loosely folded and blood in the wire lumen.Analysis of the tip, balloon, inner/ outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube, and shaft damage (cuts/ perforations) located 7.3cm from the tip.Inspection of the rest of the device found no other damage or defect with the returned device.The guide used in the procedure was not returned for analysis, so a guide catheter and guide wire were used for device to device testing.The tip of the balloon catheter was inserted into the hub of the guide catheter and advanced.The balloon catheter advanced easily and without issue.The tip was also loaded onto a guide wire and advanced, with the catheter moving easily and without issue over the wire.The reported guide difficulty was not confirmed.
Event or Problem Description
Reportable based on device analysis completed on 19-jan-2021.It was reported that difficulty advancing through the guide catheter occurred.A 30mm x 2.25mm nc quantum apex balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon did not advance over the guide catheter.The procedure was completed with another of the same device.There were no patient complication reported.However, returned device analysis revealed shaft hole in 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: 11276666
• Report Number: 2134265-2021-00965
• Device Sequence Number: 17236210
• Product Code: LOX
• UDI-Device Identifier: 08714729783565
• UDI-Public: 08714729783565
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 03/13/2022
• Device Model Number: 6534
• Device Catalogue Number: 6534
• Device Lot Number: 0023485729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1