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

Model Number	6533
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city - (b)(6).
Event or Problem Description
It was reported that an additional marker band was on the device.An emerge balloon catheter was selected for use and advanced into the patient.It was observed that the emerge balloon catheter had 3 marker bands instead of 2.The emerge balloon catheter was not dilated.The emerge was removed and replaced to complete the procedure.No patient harm resulted in relation to this event.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that an additional marker band was on the device.An emerge balloon catheter was selected for use and advanced into the patient.It was observed that the emerge balloon catheter had 3 marker bands instead of 2.The emerge balloon catheter was not dilated.The emerge was removed and replaced to complete the procedure.No patient harm resulted in relation to this event.It further reported that the target lesion was right coronary artery (rca).
Event or Problem Description
It was reported that an additional marker band was on the device.An apex balloon catheter was selected for use and advanced into the patient.It was observed that the apex balloon catheter had 3 marker bands instead of 2.The apex balloon catheter was not dilated.The apex was removed and replaced to complete the procedure.No patient harm resulted in relation to this event.It further reported that the target lesion was right coronary artery (rca).It was additionally reported that the upn of the device was an apex balloon catheter and not the emerge as it was originally reported.
Additional Manufacturer Narrative
E1: initial reporter city - (b)(6).Correction to the medical device was corrected from emerge to nc quantum apex.Device evaluated by manufacturer: returned product consisted of an nc quantum apex balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and within the folds blood was present.There were 3 markerbands present to the balloon.The proximal and distal markerband were in their respective locations, however, the third markerband was found placed within the distal cone of the balloon near the tip of the device.Inspection of the remainder of the device, presented no other damage or irregularities.Product analysis confirmed the reported event, as the device was found to have an additional markerband.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15285771
• Report Number: 2124215-2022-32351
• Device Sequence Number: 7138913
• Product Code: LOX
• UDI-Device Identifier: 08714729783527
• UDI-Public: 08714729783527
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2022

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: 11/03/2024
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0028325418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 10/13/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/06/2022; 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown