Angiographic Guide Wire 007044Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169856738), received between Feb 14, 2019 and Nov 2, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionNov 2, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ANGIO GUIDEWIRE IN A NON CALCIFIED AND NON TORTUOUS LESION IN THE OSTIUM RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE ON INSPECTION. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT AFTER REMOVAL OF THE DEVICE FROM THE PATIENT DAMAGE WAS NOTED. THE DAMAGE WAS NOTED 5-7CM FROM THE TIP OF THE DEVICE. NO RESISTANCE WAS NOTED AND EXCESSIVE FORCE WAS NOT USED DURING WITHDRAWAL OF THE DEVICE. IMAGES PROVIDED SHOW A PROTRUDING WIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10769055 ↗
• MalfunctionJul 6, 2020Material Deformation; Material Deformation

  AN ANGIOGRAPHIC GUIDE WIRE WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE WIRE BECAME FRAYED AND UNCOILED UPON REMOVING FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10231960 ↗
• MalfunctionApr 30, 2019Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ANGIOGRAPHIC GUIDEWIRE WAS ATTEMPTED TO BE USED. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING PER IFU. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE COATING WAS MOISTENED PRIOR TO USE. IT IS STATED THAT WIRES ARE TAKEN OUT OF THE PACKAGING AND ARE SOMETIMES LEFT ON THE TABLE UNDER A MOIST TOWEL BUT NOT SOAKED IN A BOWL OF NORMAL SALINE. IT WAS NOTED THAT WHEN THE WIRE WAS WIPED DOWN WITH NORMAL SALINE AND A TYPICAL GAUZE, SMALL BITS OF GREEN MATERIAL AND GREEN STAINING WERE IDENTIFIED ON THE GAUZE SPONGE. IT IS INDICATED THAT THE WIPING TOOK PLACE AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. IT CANNOT BE CONFIRMED IF THERE WERE ANY FRAGMENTS LEFT IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564835 ↗
• MalfunctionFeb 14, 2019Material Deformation; Material Deformation

  THERE WAS NO DAMAGE NOTED TO THE ANGIO GRAPHIC WIRE PACKAGING. THE WIRE WAS REMOVED FROM PACKAGING PER IFU. ON INSPECTION THE WIRE WAS NOTED TO BE DAMAGED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE WIRE WAS NOT PREPPED. ISSUE WAS NOTED PRIOR TO USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339383 ↗