NC Quantum Apex™ H7493912430300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729783596), received between Aug 5, 2021 and Jan 26, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2023Contamination; Material Integrity Problem; Packaging Problem; Contamination; Material Integrity Problem; Packaging Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. WHEN A 30MM X 3.00MM NC QUANTUM APEX BALLOON CATHETER ARRIVED, IT WAS NOTED THAT THE BALLOON AS WELL AS THE INNER PACKAGING WERE CRUSHED AND DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246593 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2021, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. HEPARIN OR ANTITHROMBOTIC MEDICATION GP IIB/IIIA INHIBITOR WERE ADMINISTERED AT THE TIME OF INDEX PROCEDURE. THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS) AT THE TIME OF INDEX PROCEDURE AND LOADING DOSE OF 300 MG OF CLOPIDOGREL WAS GIVEN PRIOR TO THE PROCEDURE. THE TARGET LESION 1 WAS LOCATED AT THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER WAS 3.00 MM. THE TARGET LESION WAS PREDILATED WITH 3.00 MM X 30 MM BALLOON WITH 30% RESIDUAL STENOSIS. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH 3.00 MM X 30 MM NC QUANTUM APEX PLAIN OLD BALLOON ANGIOPLASTY (POBA) SUCCESSFULLY WITH 30% RESIDUAL STENOSIS. POST-DILATION WAS NOT PERFORMED. THE BASELINE CARDIAC ENZYMES WERE AS FOLLOWS: CK-MB: 2.6 NG/ML (REFERENCE RANGE: 7.7 NG/ML). TROPONIN T: 0.199 NG/ML (REFERENCE RANGE: 22 NG/ML). ON THE FOLLOWING DAY, ELEVATION OF CK-MB WAS NOTED CONSISTENT WITH PROTOCOL DEFINITION OF MYOCARDIAL INFARCTION. PEAK CK-MB: 113.2 NG/ML (REFERENCE RANGE: 7.7 NG/ML). ELE

  Patient problems: Myocardial Infarction; Restenosis; Vasoconstriction

  MAUDE report 12284835 ↗