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

Model Number	H7493912408250
Medical Device Problem Codes	Contamination (1120); Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact date of event was not provided.G4 premarket / 510(k): k121667, k160823.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that device contamination occurred.A 8mm x 2.50mm nc quantum apex balloon catheter was selected for use.However, during the procedure it was noted that the device was contaminated.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact date of event was not provided.G4 premarket / 510(k): k121667, k160823.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Nc quantum apex mr 8mm x 2.50mm was returned for analysis.The device was received inside its opened, damaged outer box.The box was creased and dented.The sterile inner pouch was not returned for analysis.The device was received in three sections due to two breaks in the hypotube shaft.One break was located at 39.1cm distal to the distal end of the strain relief, and the other break was located at 73.7cm proximal from the tip.A middle section of hypotube measuring 28cm in length, was also received and this section was kinked in multiple locations.No kinks or damages.Microscopic analysis revealed no damage was identified during a microscopic examination of the extrusion shaft.There was traces of what appears to be blood inside the inner lumen.A detailed microscopic examination of the balloon material identified no damages.The balloon was folded.A microscopic examination of the tip section found no damage.
Event or Problem Description
It was reported that device contamination occurred.A 8mm x 2.50mm nc quantum apex balloon catheter was selected for use.However, during the procedure it was noted that the device was contaminated.There were no patient complications reported.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21689526
• Report Number: 2124215-2025-16076
• Device Sequence Number: 21097156
• Product Code: LOX
• UDI-Device Identifier: 08714729783138
• UDI-Public: 08714729783138
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 10/31/2022
• Device Model Number: H7493912408250
• Device Catalogue Number: H7493912408250
• Device Lot Number: 0024695365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• 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