Angiographic Guide Wire 007447Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169856844), received between Sep 10, 2018 and Sep 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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.

• MalfunctionSep 22, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ANGIOGRAPHIC GUIDEWIRE DURING A CARDIAC PROCEDURE. THE DEVICE WAS NOT INSPECTED BEFORE USE. RESISTANCE WAS NOT NOTED DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT THE OUTER SPIRALED LAYER OF THE WIRE UNRAVELED AT THE DISTAL END WHERE THERE IS A GAP BETWEEN THE SPIRAL LAYERS. THE ISSUE OCCURRED WHILE REMOVING THE WIRE FROM THE NON-MEDTRONIC GUIDE CATHETER OUTSIDE THE PATIENT, AFTER THE DEVICE HAD BEEN INSIDE THE PATIENT. THE DEFORMATION AND DETACHMENT WERE NOTED AFTER THE DEVICE WAS REMOVED. RESISTANCE WAS NOT NOTED DURING WITHDRAWAL OF THE DEVICE. THE DETACHED PORTION OF THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE GUIDE CATHETER AND DISCARDED. IT WAS ALSO DETAILED THAT THE SAME ISSUE OCCURRED WITH A NON-MEDTRONIC GUIDEWIRE AT THE BEGINNING OF THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797012 ↗
• MalfunctionJan 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED IN PE 703553375 0.035 X 145CM PTFE GUIDE WIRES BECAME DEFORMED DURING SEVERAL PROCEDURES. IT WAS REPORTED THAT THE OUTER CORE OF THE WIRE SEPARATED FROM THE INNER CORE OF THE WIRE. THERE WAS NO IMPACT TO THE PATIENT AND THEIR CURRENT STATUS IS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9620084 ↗
• MalfunctionJan 23, 2020Material Deformation; Material Deformation

  A 0.035 X 145CM PTFE GUIDE WIRE WAS USED DURING A PROCEDURE TO TREAT A NON TORTUOUS, NON CALCIFIED LESION. IT WAS REPORTED THAT THE OUTER CORE OF THE WIRE SEPARATED FROM THE INNER CORE OF THE WIRE. THE PATIENT IS ALIVE WITH NO INJURY. THEIR WAS NO IMPACT TO THE PATIENT AND THEIR CURRENT STATUS IS GOOD. SR (B)(4) WAS CREATED FOR THE COMMENT "IT HAS OCCURRED ON/DURING SEVERAL PROCEDURES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9620048 ↗
• MalfunctionSep 10, 2018Material Deformation; Material Deformation

  THE ANGIO GRAPHIC J WIRE WAS INITIALLY OBSERVED AND UTILIZED IN THE LEFT PROXIMAL POPLITEAL ARTERY WITHOUT ISSUE. THE WIRE WAS PREPPED FOR USE AS PER THE IFU. THE TARGET LESION HAD PLAQUE PRESENT, LITTLE CALCIFICATION, LITTLE TORTUOSITY AND 40-50% STENOSIS. NO RESISTANCE WAS FELT ADVANCING THE WIRE. UPON THE 4TH USE AND REMOVAL OF THE J WIRE FROM THE CATHETER, IT WAS NOTICED THE WIRE SEEMED LONGER THAN EARLIER USAGE AND UPON FURTHER OBSERVATION, A SMALLER TRANSITION IN DIAMETER OF THE WIRE WAS ALSO NOTICED AT THE DISTAL END. FLUOROSCOPY WAS UTILIZED BY THE PHYSICIAN TO CONFIRM THAT THE ENTIRE WIRE WAS REMOVED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859542 ↗