Inoue Balloon Catheter PTMC-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14960685200030), received between Sep 26, 2018 and Jun 27, 2019 — classified as 1 death, 1 injury.

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.

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.

• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUSTAINED, WHAT INITIALLY APPEARED TO BE, A CHORD RUPTURE AFTER 2ND INFLATION AT 23MM. SEPTAL CROSSING WAS IN PROPER LOCATION WITH UNCOMPLICATED CROSSING OF MITRAL VALVE ON BOTH INFLATION ATTEMPTS, NO EMPASSE SIGN NOTED. AFTER INFLATION SEVERE CONCENTRIC MR JET NOTED ON ECHO WITH TEMPORARY DROP IN PATIENT'S PAO2. PT'S BP, SATS, WERE STABLE WITHOUT ADDITIONAL INTERVENTION. SURGICAL CONSULT COMPLETED AND PATIENT TAKEN TO OR FOR VALVE REPLACEMENT. PT'S CORONARIES WERE ASSESSED PRIOR TO SURGERY AND RIGHT MAIN WAS OCCLUDED RESULTING IN A SURGICAL PLAN OF MV REPLACEMENT, GRAFTING FOR OCCLUSION, CLIPPING OF ATRIAL APPENDAGE AND ABLATION FOR AFIB. INITIAL ASSESSMENT FOR PATIENT FOR SURGICAL INTERVENTIONS ARE GOOD.

  Patient problems: Mitral Regurgitation; Rupture

  MAUDE report 8742091 ↗
• DeathSep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATRIAL APPENDAGE LACERATION WITH SECONDARY CARDIAC TAMPONADE REQUIRING EMERGENCY SURGERY TO CORRECT. VALVE ANATOMY WAS DEEMED SUITABLE FOR COMMISSUROTOMY BUT LARGE LEFT ATRIUM WITH HIGH DEGREE OF ATRIAL SEPTAL DEVIATION NOTED. TRANSSEPTAL PUNCTURE COMPLETED AT 3.7CM HEIGHT WITHOUT INCIDENT. WIRE INTRODUCED, SEPTUM DILATED TWICE AND DEVICE ADVANCED OVER THE WIRE. SEPTAL CROSSING, AND SYSTEMATIC ADVANCE AROUND ATRIUM AND ABOVE MITRAL VALVE ALSO UNREMARKABLE. GUIDE WIRE AND STRETCHING TUBE REMOVED STYLET INTRODUCED. SEVERAL ATTEMPTS TO CROSS MITRAL VALVE WERE UNSUCCESSFUL, ALWAYS LYING OVER POSTERIOR ASPECT OF VALVE, UNABLE TO OBTAIN ADEQUATE ANGLE TO CROSS MITRAL VALVE. WIRE REINTRODUCED AGAIN AND DEVICE REPOSITIONED, AGAIN MULTIPLE ATTEMPTS UNSUCCESSFUL. WIRE REINTRODUCED AND DEVICE ADVANCED RETROGRADE DIRECTION OVER WIRE (THE LOOP METHOD) TO GAIN BETTER ANGLE ON MITRAL VALVE, THIS WAS ALSO UNSUCCESSFUL DUE TO LARGE SIZE OF ATRIUM, DEVICE WOULD NOT MAINTAIN RETROGRADE ORIENTATION. WIRE REINTRODUCED AND DEVICE ADVANCED TO MITRAL VALVE AGAIN, AFTER SEVERAL UNSUCCESSFUL ATTEMPTS AN EFFUSION WAS NOTED AT LEFT ATRIUM/LEFT VENTRICLE AREA OF PERICARDIUM. CASE WAS ABORTED DUE TO VELOCI

  Patient problems: Cardiac Tamponade

  MAUDE report 7911209 ↗