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

Model Number	6533
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon issues occurred.The 20mm x 3.50mm quantum nc apex balloon was selected for use.The balloon catheter was placed on negative pressure and inserted into the guide catheter.As the balloon advanced over the aortic arch, it was noted that it appeared minimally inflated.The device was removed, and the balloon was found to contain contrast and was not fully deflated as it should be with negative pressure applied.The device was tested outside the patient and was not inflating and deflating optimally.The procedure was completed with another device.There were no patient complications, and the patient condition was stable.
Additional Manufacturer Narrative
The nc quantum apex mr 20mm x 3.50mm was returned for analysis.Visual, tactile and microscopic analysis as well as functional testing was performed on the device.No issues were identified during analysis.The device was attached to an encore inflation unit and the balloon was inflated successfully and without issue.Inflation was to the rate burst pressure (rbp) of 20 atmospheres (atm) as per instructions for use.The balloon was able to deflate in 10 seconds without issue.The allegation in the complaint was not confirmed.
Event or Problem Description
It was reported that balloon issues occurred.The 20mm x 3.50mm quantum nc apex balloon was selected for use.The balloon catheter was placed on negative pressure and inserted into the guide catheter.As the balloon advanced over the aortic arch, it was noted that it appeared minimally inflated.The device was removed, and the balloon was found to contain contrast and was not fully deflated as it should be with negative pressure applied.The device was tested outside the patient and was not inflating and deflating optimally.The procedure was completed with another device.There were no patient complications, and the patient condition was stable.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19235135
• Report Number: 2124215-2024-26967
• Device Sequence Number: 20821414
• Product Code: LOX
• UDI-Device Identifier: 08714729783503
• UDI-Public: 08714729783503
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 05/22/2026
• Device Model Number: 6533
• Device Catalogue Number: 6533
• Device Lot Number: 0031681060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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