OPN NC 300-010-004Recalls & reported problems
SIS Medical AG · OPN NC Ø3.0x10 PTCA catheters · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640142570561), received between Mar 16, 2025 and Mar 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2025Material Rupture; Material Rupture
TREATMENT OF MID LAD (LEFT ANTERIOR DESCENDING CORONARY ARTERY) IN-STENT RESTENOSIS WITH MINOR STENT UNDER EXPANSION. STENOSIS DEGREE OF 40%. BALLOON RUPTURE/BURST AFTER 2-4 SECONDS OF INFLATION, AT INFLATION PRESSURE 25 ATM.CARDIOLOGIST SUSPECTED THE OPN BALLOON BURST UPON INFLATION AND WAS THE PROBABLE CAUSE OF THE MECHANISM FOR RUPTURE OF LAD. BALLOON WAS REPORTED TO HAVE SUDDENLY LOST PRESSURE AT 25 ATM DURING INFLATION. OPN BALLOON WAS DEFLATED WITH BLOOD STAINING NOTED IN THE FLUID OF THE INFLATION DEVICE, WHICH IS INCONSISTENT WITH BALLOON RUPTURE. EVIDENCE OF ARTERY RUPTURE NOTED ANGIOGRAPHICALLY. CARDIAC ARREST FOLLOWED. LAD RUPTURE TREATED WITH PAPYRUS COVERED STENT, TAMPONADE WAS DRAINED AND THE PATIENT SUCCESSFULLY RESCUSISTATED AND TRANSFERED TO ICU.
Patient problems: Cardiac Arrest
MAUDE report 21615285 ↗
Other Catheters, Transluminal Coronary Angioplasty, Percutaneous devices
- MINI TREK™ 1012270-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous223 reports
- Maverick²™ H7493892815200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous1 death203 reports
- MINI TREK™ 1012270-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous162 reports
- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page