Luge™ H7491210001J0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729169949), received between Apr 25, 2019 and Jul 2, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH# MW5094849 THAT TIP DETACHMENT AND PERFORATION OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED RAMUS BRANCH. A 300CM J LUGE GUIDEWIRE WAS USED TO CROSS THE LESION ALONG WITH ANOTHER WIRE. CUTTING BALLOONS AND NON-COMPLIANT BALLOON CATHETERS WERE USED FOR DILATATION. HOWEVER, UPON WIRE REMOVAL, THE DISTAL TIP OF THE WIRE BROKE OFF AND PERFORATION WAS NOTED. SUBSEQUENTLY, EMERGENCY ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED NO PERICARDIAL EFFUSION. THE DETACHED FRAGMENT WAS LEFT IN PLACE AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS HEMODYNAMICALLY STABLE AND WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 10224563 ↗
• InjuryJun 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT VESSEL PERFORATION AND TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RAMUS ARTERY. A LUGE 300CM J GUIDEWIRE WAS USED TO ACCESS THE TARGET LESION. MULTIPLE BALLOON INFLATION WERE PERFORMED BEFORE THE STENT WAS DEPLOYED. HOWEVER, WHEN THE WIRE WAS REMOVED, THE DISTAL TIP OF THE WIRE REMAINED IN THE PATIENT AND A SMALL PERFORATION WAS NOTED. NO EFFUSION WAS SEEN AND THE PATIENT DID WELL POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 10189932 ↗
• MalfunctionMar 30, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 300CM J LUGE GUIDEWIRE WAS SELECTED FOR USE. THE LESION WAS SUCCESSFULLY TREATED. HOWEVER, THE WIRE WAS FRACTURED AT THE DISTAL TIP UPON REMOVAL FROM THE LESION. THE WIRE WAS REMOVED IN ONE PIECE, BUT WAS OBSERVED TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898317 ↗
• InjuryApr 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A BALLOON WEDGE 5FR CATHETER WAS SELECTED FOR USE. HOWEVER, THE DEVICE WAS UNABLE TO BE ADVANCED IN THE LEFT BRACHIAL VEIN. A 300CM J LUGE GUIDEWIRE WAS USED TO HELP THE BALLOON TO CROSS A NARROWING IN THE ARM. AS THE WIRE WAS ADVANCED, IT WAS NOTED THAT THE WIRE BENT UP ON ITSELF A LITTLE AND WHEN THE WIRE WAS SLOWLY REMOVED, IT APPEARED AS IF THE RADIO-OPAQUE TIP HAD FALLEN OFF. A SNARE WAS USED TO EXTRACT THE BROKEN PIECE OF THE WIRE FROM THE ARM. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549928 ↗