Mach1™ H74934356680Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729351955), received between Aug 21, 2024 and Aug 21, 2024 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DISSECTION OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 85% STENOSED, 4.0-4.5MMX53MM, ECCENTRIC, DE NOVO TARGET LESION WITH A BEND OF >45 AND <90 DEGREES WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MIDDLE RIGHT CORONARY ARTERY (RCA). AN OPTICROSS IMAGING CATHETER WAS USED TO STUDY THE MORPHOLOGY OF THE LESION. AFTER A MACH1 JR 4 6F GUIDE-CATHETER WAS ENGAGED COAXIALLY AND A SAMURAI GUIDEWIRE CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH A 3.50MM X 15MM EMERGE BALLOON CATHETER. WITH THE HELP OF 6F GUIDEZILLA LONG CATHETER-GUIDE EXTENSION, A 4.0MM X 20MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED. A 4.0MM X 12MM NC EMERGE BALLOON CATHETER WAS THEN USED FOR POST DILATION. USING THE SAME OPTICROSS DEVICE, THE PHYSICIAN NOTED THAT A TYPE E DISSECTION HAD OCCURRED FROM THE PROXIMAL TO THE OSTIAL PART OF THE RCA. THE DISSECTION WAS CONSIDERED TO HAVE BEEN CAUSED BY THE GUIDEZILLA AND MACH1 CATHETERS. WHEN THEY WERE USED RESISTANCE WAS FELT, AND THE DEVICES WERE ENGAGED DEEPLY INTO THE RCA CAUSING THE DISSECTION. THE

  Patient problems: Vascular Dissection

  MAUDE report 20021026 ↗