MIRACLEBROS 6 AG14M060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327056083), received between Jun 20, 2023 and Jun 23, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

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 23, 2023Fracture; Fracture

  THIS IS AN EXERT FROM THE PROCEDURAL NOTE DESCRIBING THE FRACTURE OF A ''MIRACLE BROTHER WIRE'. APPROXIMATELY 13.2 MM OF WIRE REMAINED BEHIND. WHILE "TRYING TO PENETRATE THE DISTAL CAP OF A CORONARY VESSEL WITH A MIRACLE BROTHERS WIRE, IT APPEARED AS THOUGH THE WIRE HAD GONE SUBINTIMAL ON RETROGRADE INJECTION. WHEN THE MIRACLE BROTHER WIRE WAS ATTEMPTED TO BE RETRACTED THERE WAS RESISTANCE SO INITIAL ATTEMPTS WERE MADE TO REMOVE THE WIRE AS A UNIT WITH THE TURNPIKE MICROCATHETER AND THEN THE XB 3.5 GUIDE CATHETER UNTIL THE NO MORE RESISTANCE WAS NOTED BUT ON ANGIOGRAPHY IT APPEARED THAT THE FLOPPY TIP OF THE MIRACLE BROTHER WIRE HAD FRACTURED INTO THE SUBINTIMAL SPACE WHICH WAS CONFIRMED ON ORTHOGONAL AND DUAL ANGIOGRAPHIES. AS THE WIRE WAS REMOVED FROM THE BODY IT WAS CONFIRMED ON GROSS EXAMINATION THAT IT WAS THE FLOPPY TIP OF THE WIRE WHICH HAD FRACTURED AND WAS LEFT IN THE SUBINTIMAL SPACE. AS THERE WAS NO CHANGE IN THE CLINICAL STATUS OF THE PATIENT WITH INTACT HEMODYNAMICS, STABLE EKG FINDINGS, AND LACK OF WORSENING CHEST PAIN WE DECIDED AGAINST SNARING THE FRACTURED WIRE TIP DUE TO THE RISKS VS BENEFITS AS IT WAS IN THE SUBINTIMAL SPACE AND UNLIKELY TO BECOME THROMBOGENIC IN

  Patient problems: Insufficient Information

  MAUDE report 17195704 ↗
• InjuryJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  USER FACILITY REPORT (REPORT #:MW5117733) WAS RECEIVED FROM THE US DISTRIBUTOR. IT WAS REPORTED THAT THE TIP OF AN ASAHI MIRACLEBROS 6 GUIDE WIRE HAD FRACTURED AND APPROXIMATELY 13.2MM OF THE WIRE TIP REMAINED IN THE PATIENT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE UNSPECIFIED CORONARY ARTERY. THE GUIDE WIRE WAS USED TO PENETRATE THE DISTAL CAP OF THE CTO. IT APPEARED AS THOUGH THE GUIDE WIRE HAD GONE SUBINTIMAL ON RETROGRADE INJECTION ANGIOGRAM. WHEN THE GUIDE WIRE WAS ATTEMPTED TO BE RETRACTED, THERE WAS RESISTANCE. INITIAL ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE AS A UNIT WITH A NON-ASAHI TURNPIKE MICROCATHETER AND THEN A NON-ASAHI XB 3.5 GUIDE CATHETER UNTIL NO MORE RESISTANCE WAS NOTED. BUT ON ANGIOGRAPHY IT APPEARED THAT THE FLOPPY TIP OF THE GUIDE WIRE HAD FRACTURED INTO THE SUBINTIMAL SPACE WHICH WAS CONFIRMED ON ORTHOGONAL AND DUAL ANGIOGRAPHIES. AS THE GUIDE WIRE WAS REMOVED FROM THE BODY IT WAS CONFIRMED ON GROSS EXAMINATION THAT IT WAS THE FLOPPY TIP OF THE WIRE WHICH HAD FRACTURED AND WAS LEFT IN THE SUBINTIMAL SPACE. AS THERE WAS NO CHANGE IN THE CLINICAL STATUS OF THE PATIENT WITH INTACT HEMODYNAMICS, STABL

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17167917 ↗