Angiographic Guide Wire 008631Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169857124), received between Sep 18, 2018 and Aug 23, 2021 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2021Entrapment of Device; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Entrapment of Device; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE AN ANGIOGRAPHIC GUIDE WIRE AND A LAUNCHER GUIDE CATHETER TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE NOT INSPECTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED ON THE WIRE IN VIVO AND THAT THE DEVICE WAS TRAPPED IN THE PATIENT. AFTER THE STENT PLACEMENT THE PHYSICIAN WAS UNABLE TO PROCEED WITH THE LAUNCHER GUIDE CATHETER BECAUSE IT WAS STUCK IN THE WIRE. IT WAS STATED THAT AFTER MULTIPLE ATTEMPTS A KINK OCCURRED IN THE GUIDE CATHETER AND THE WIRE KINKED AND BROKE AT THE DISTAL TIP, WITH 3 CM OF THE TIP REMAINING IN THE ARTERY. THE FRAGMENT WAS NOT REMOVED AS THE PHYSICIAN CONSIDERED THAT THE BODY WOULD CREATE TISSUE AROUND IT. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12352885 ↗
• MalfunctionFeb 19, 2021Material Deformation; Material Deformation

  DURING AN ANGIOGRAM PROCEDURE, ONE ANGIOGRAPHIC GUIDE WIRE WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT A J-TIP EXCHANGE WIRE WAS USED TO GUIDE THE PIGTAIL CATHETER INTO THE VENTRICULAR. WHEN THE J-TIP WIRE WAS REMOVED IT WAS NOTED TO HAVE THE INNER WIRE POKINGTHROUGH THE SIDE OF THE MOVEABLE EXTERIOR. IT WAS STATED THAT THE J-TIP WIRE PROTRUDED THROUGH THE EXTERIOR WALL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348613 ↗
• MalfunctionNov 12, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE ANGIOGRAPHIC GUIDEWIRES TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EXHIBITING NO STENOSIS IN THE AORTA. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STRETCHED COILS WERE NOTED AFTER THE DEVICE WAS REMOVED OUT OF THE GUIDE. IT WAS STATED THAT UPON REMOVAL A CATCH WAS FELT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 10827781 ↗
• MalfunctionDec 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A 0.035¿ ANGIOGRAPHIC WIRE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE ANGIOGRAPHIC WIRE WAS FRAYED AT THE START OF THE J-TIP. THE TIP DID NOT DETACH. THE DAMAGE WAS NOTICED UPON REMOVING THE WIRE FROM THE GUIDE CATHETER. PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449182 ↗
• MalfunctionOct 30, 2019Fracture; Material Deformation; Fracture; Material Deformation

  AN ANGIOGRAPHIC GUIDE WIRE WAS USED DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THE GUIDE WIRE UNRAVELED INSIDE THE CALIBRATED PIG GUIDE, THE WIRE FRACTURED WHILE BEING USED AND THEN CAUSED THROMBUS TO FORM IN THE WIRE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254486 ↗
• MalfunctionSep 11, 2019Material Integrity Problem; Material Integrity Problem

  A 0.035" ANGIOGRAPHIC WIRE WAS USED DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER THE IFU WITH NO ISSUES. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED. THE COATING WAS MOISTENED PRIOR TO USE. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION. IT WAS REPORTED THAT WHEN THEY EXCHANGED THE CATHETERS OVER THE WIRE TO GET INTO THE LEFT INTERNAL MAMMARY ARTERY IN THE AORTA THEY NOTICED GREEN COATING COMING OFF THE WIRE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8987857 ↗
• MalfunctionJul 17, 2019Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ANGIOGRAPHIC WIRE WAS USED DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS PREPPED AS PER IFU. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT GREEN COATING CAME OFF AFTER THE WIRE WAS WITHDRAWN FROM THE PATIENT. THE COATING WAS NOTED ON THE 4 X 4 WIPE DURING THE PROCEDURE FROM THE EXCHANGE WIRE. THE WIPE WAS WET WITH NORMAL SALINE SOLUTION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797132 ↗
• MalfunctionMay 23, 2019Peeled/Delaminated; Peeled/Delaminated

  TWO ANGIOGRAPHIC WIRES WERE USED TO DELIVER A DIAGNOSTIC CATHETER TO THE OSTIUM. THE LESION WAS REPORTED AS BEING NON TORTUOUS, HAD NO CALCIFICATION AND % STENOSIS WAS ZERO. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENTS ANATOMY. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING PER THE IFU. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE WIRE TIPS WERE NOT FORMED BY THE PHYSICIAN. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED, HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS NOTED THAT THERE WAS A WIRE COATING ISSUE WHERE BY A GRITTINESS WAS FELT WHEN REMOVING THE WIRES FROM THE CATHETER. WHEN THE WIRES WERE SUBSEQUENTLY WIPED DOWN THERE WAS A SILVER/GREY METALLIC STAIN NOTED ON THE WIPING GAUZE. IT WAS REPORTED THAT THE COATING WAS MOISTENED PRIOR TO USE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636144 ↗
• MalfunctionMay 23, 2019Peeled/Delaminated; Peeled/Delaminated

  TWO ANGIOGRAPHIC WIRES WERE USED TO DELIVER A DIAGNOSTIC CATHETER TO THE OSTIUM. THE LESION WAS REPORTED AS BEING NON TORTUOUS, HAD NO CALCIFICATION AND % STENOSIS WAS ZERO. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENTS ANATOMY. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING PER THE IFU. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE WIRE TIPS WERE NOT FORMED BY THE PHYSICIAN. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED, HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS NOTED THAT THERE WAS A WIRE COATING ISSUE WHERE BY A GRITTINESS WAS FELT WHEN REMOVING THE WIRES FROM THE CATHETER. WHEN THE WIRES WERE SUBSEQUENTLY WIPED DOWN THERE WAS A SILVER/GREY METALLIC STAIN NOTED ON THE WIPING GAUZE. IT WAS REPORTED THAT THE COATING WAS MOISTENED PRIOR TO USE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8635853 ↗
• MalfunctionApr 29, 2019Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  IT WAS REPORTED THAT DURING NORMAL WIPING OF THE ANGIOGRAPHIC WIRE WITH A GAUZE PAD, GREEN RESIDUE WAS NOTED ON THE PAD. IT IS INDICATED THAT THE WIPING WAS DONE AFTER REMOVAL FROM THE PATIENT'S BODY. IT WAS SUGGESTED THAT THE GREEN COATING ON THE WIRE WAS BREAKING OFF. IT CANNOT BE CONFIRMED IF THERE WERE ANY FRAGMENTS LEFT IN THE PATIENT. NO DAMAGE WAS NOTED TO THE PACKAGING, NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES AND THE DEVICE WAS PREPPED PER THE IFU. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560228 ↗
• MalfunctionApr 29, 2019Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ANGIOGRAPHIC GUIDE WIRE CATHETER WAS ATTEMPTED TO BE USED DURING A PROCEDURE. NO DAMAGE WAS NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING AS PER IFU WITH NO ISSUES.THE DEVICE WAS PREPPED PER THE IFU WITH ISSUES NOTED. THE COATING WAS MOISTENED PRIOR TO USE. IT IS REPORTED THAT DURING NORMAL WIPING WITH A 4 X 4 GAUZE PAD, GREEN RESIDUE WAS NOTED ON THE PAD. IT IS INDICATED THAT THE WIPING WAS DONE AFTER REMOVAL FROM THE PATIENT'S BODY. IT CANNOT BE CONFIRMED IF THERE WERE ANY FRAGMENTS LEFT IN THE PATIENT. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560094 ↗
• MalfunctionApr 11, 2019Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ANGIOGRAPHIC WIRE WAS ATTEMPTED TO BE USED DURING A PROCEDURE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED TO DEVICE WHEN REMOVING FROM THE PACKAGING AS PER IFU. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. IT IS REPORTED THAT THERE WAS A WIRE COATING ISSUE. AS PER THE NURSE WHO REPORTED THE INCIDENT TO THE MATERIALS COORDINATOR, DURING NORMAL WIPING WITH A GAUZE AS PER INTRAPROCEDURAL TECHNIQUE, GREEN RESIDUE WAS NOTED ON THE PAD, SUGGESTING THE GREEN COATING ON THE WIRE WAS BREAKING OFF. IT IS INDICATED THAT THE DEVICE ENTERED THE PATIENT BODY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503571 ↗
• MalfunctionApr 11, 2019Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ANGIOGRAPHIC WIRE WAS ATTEMPTED TO BE USED DURING A PROCEDURE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED TO DEVICE WHEN REMOVING FROM THE PACKAGING AS PER IFU. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. IT IS REPORTED THAT THERE WAS A WIRE COATING ISSUE. AS PER THE NURSE WHO REPORTED THE INCIDENT TO THE MATERIALS COORDINATOR, DURING NORMAL WIPING WITH A GAUZE AS PER INTRAPROCEDUAL TECHNIQUE, GREEN RESIDUE WAS NOTED ON THE PAD, SUGGESTING THE GREEN COATING ON THE WIRE WAS BREAKING OFF. IT IS INDICATED THAT THE DEVICE ENTERED THE PATIENT BODY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503538 ↗
• MalfunctionApr 11, 2019Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ANGIOGRAPHIC WIRE WAS ATTEMPTED TO BE USED DURING A PROCEDURE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED TO DEVICE WHEN REMOVING FROM THE PACKAGING AS PER IFU. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. IT IS REPORTED THAT THERE WAS A WIRE COATING ISSUE. AS PER THE NURSE WHO REPORTED THE INCIDENT TO THE MATERIALS COORDINATOR, DURING NORMAL WIPING WITH A GAUZE AS PER INTRAPROCEDURAL TECHNIQUE, GREEN RESIDUE WAS NOTED ON THE PAD, SUGGESTING THE GREEN COATING ON THE WIRE WAS BREAKING OFF. IT IS INDICATED THAT THE DEVICE ENTERED THE PATIENT BODY. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503422 ↗
• MalfunctionSep 18, 2018Material Deformation; Material Deformation

  THE FACILITY HAS HAD MULTIPLE ISSUES WITH THE WIRES KINKING. THEY DECIDED TO SWITCH TO ANOTHER PROVIDER AND THOSE WORKED BETTER. WHEN THOSE WENT ON BACK ORDER, THEY GAVE THE MEDTRONIC DEVICES ANOTHER TRY AND STILL FOUND THE SAME ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7884583 ↗