RUNTHROUGH 25-1011 (REF TW*AS418XA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 04987350779373), received between Nov 14, 2016 and Jul 15, 2026 — classified as 2 deaths, 87 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (40 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2026Peeled/Delaminated; Unraveled Material

  TERUMO MEDICAL RECEIVED THE FOLLOWING INFORMATION: DURING A PCI, THE RUNTHROUGH NS 180 CM WIRE WAS USED TO WIRE THE LESION. THE PROXIMAL PORTION OF THE WIRE UNRAVELED AND SHEARED OFF IN THE CIRCUMFLEX PATIENT STARTED HAVING BRADYCARDIA. THE DOCTOR SAW EVIDENCE OF PLAQUE SHIFTING TOO. THEREFORE, AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED TO SEE INSIDE THE VESSEL. A SECOND RUNTHROUGH NS WIRE WAS OPENED AND USED TO FINISH THE CASE. A 3.5X16MM (CORONARY STENT) WAS PLACED TO TACK THE SHEARED OFF WIRE AND PLAQUE TO THE WALL OF THE CIRCUMFLEX AND FLOW WAS RESTORED. THE PATIENT WAS DOING WELL AND WAS NOT HAVING ANY ISSUES AT THAT POINT. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25827440 ↗
• InjuryJul 14, 2026Break; Unintended Deflation

  TERUMO MEDICAL RECEIVED THE FOLLOWING INFORMATION: THE RT GOT JAILED/STUCK BETWEEN STENT AND TISSUE DURING A LEFT HEART CATH (LHC). THE DOCTOR TRIED BALLOONING OVER THE WIRE TO RELEASE; HOWEVER, THAT DID NOT WORK. THE PULLED ON THE RT WIRE AND IT BROKE WIRE OFF AT JUNCTION POINT AS WELL AS STRETCHED WIRE. THE DOCTOR CALLED ANOTHER SURGEON AND THE PATIENT SENT TO SURGERY TO REMOVE THE WIRE; HOWEVER, THERE WERE NO DETAILS ON THE SUCCESS OR EXTENT OF THE REMOVAL. NO BLOOD LOSS WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25813186 ↗
• MalfunctionJul 14, 2026Break; Unintended Deflation

  Patient problems: Foreign Body In Patient

  MAUDE report 25812973 ↗
• InjuryFeb 12, 2026Material Fragmentation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A TINY PIECE OF THE RUNTHROUGH WIRE BROKE OFF/CAME OFF WITHIN THE PATIENT DURING THE CORONARY ANGIOGRAM CASE. TO RESOLVE THE ISSUE, THEY ATTEMPTED TO PLASTY WITH BALLOON TO "TRAP" PIECE OF WIRE AND ATTEMPTED TO SNARE. THERE WAS CALCIUM PRESENT IN PATIENT'S ANATOMY WHEN THE WIRE FRAGMENT BROKE OFF. THE CASE WAS SUCCESSFULLY COMPLETED. THE EVENT DID NOT CAUSE ANY HARM, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24326289 ↗
• InjuryFeb 12, 2026Material Fragmentation

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: A TINY PIECE OF THE RUNTHROUGH WIRE BROKE OFF/CAME OFF WITHIN THE PATIENT DURING THE CORONARY ANGIOGRAM CASE. TO RESOLVE THE ISSUE, THEY ATTEMPTED TO PLASTY WITH BALLOON TO "TRAP" PIECE OF WIRE AND ATTEMPTED TO SNARE. THERE WAS CALCIUM PRESENT IN PATIENT'S ANATOMY WHEN THE WIRE FRAGMENT BROKE OFF. THE CASE WAS SUCCESSFULLY COMPLETED. THE EVENT DID NOT CAUSE ANY HARM, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24326262 ↗
• InjuryJun 21, 2024Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated; Physical Resistance/Sticking

  THE USER FACILITY REPORTED INJURY TO A PATIENT IN THE CATHETERIZATION LAB FOR A NON-STEMI, WHERE AN ATTEMPT WAS MADE TO ASPIRATE A CLOT. USING A RIGHT RADIAL APPROACH WITH A 6F GUIDE EBU, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH A 2.5MM BALLOON WAS PERFORMED. THE PRIORITY ONE CATHETER CROSSED, AND THE CLOT WAS ASPIRATED. HOWEVER, AS THE CATHETER WAS BEING WITHDRAWN FROM THE THIRD DIAGONAL, RESISTANCE WAS ENCOUNTERED, AND ADDITIONAL FORCE USED TO REMOVE IT CAUSED THE TIP ON P1 TO DISLODGE AND REMAIN INSIDE THE CORONARY ARTERY. THE PATIENT WAS STABLE BUT WAS TRANSFERRED TO THE FOR FURTHER INTERVENTION, WHICH WAS NOT PERFORMED AS THE PATIENT REMAINED STABLE. THE PROCEDURE CONDUCTED WAS A HEART CATHETERIZATION, WITH NO BLOOD LOSS REPORTED. THE PATIENT HAS A HISTORY OF CHEST PAIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19581991 ↗
• InjuryJun 16, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED A BROKEN RUNTHROUGH WIRE TIP THAT OCCURRED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). ACCORDING TO THE TEAM THEY HAD A RUNTHROUGH WIRE TIP BREAKOFF DURING A PROCEDURE . THE PATIENT REMAINED STABLE DURING THE PROCEDURE AND NO HARM TO THE PATIENT WAS DONE. THE DOCTOR WAS PLACING A STENT IN A HEAVY CALICIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) . HE HAD A RUNTHROUGH NS WIRE DOWN THE LAD AND A SION BLUE WIRE DOWN THE DIAG. THE SION BLUE WIRE WAS PULLED BACK BEFORE STENT DEPLOYMENT . ONCE STENT (BOSTON SCIENTIFIC SYNERGY) WAS DEPLOYED AND VESSEL WAS POST DILATED ( BOSTON EMERGE) THE RUNTHROUGH WIRE WAS REMOVED . UPON REMOVING THE TIP OF THE WIRE CAME OFF IN THE LEFT MAIN. THE DECISION WAS MADE TO PIN THE WIRE TO WALL WITH AN ADDITIONAL STENT (BOSTON SCIENTIFIC MEGATRON). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. A CORONARY ARTERY STENTING AND ANGIOPLASTY WAS REQUIRED TO TRAP THE WIRE TIP IN A SECURE LOCATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19544603 ↗
• InjuryJun 15, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED A BROKEN RUNTHROUGH WIRE TIP THAT OCCURRED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). ACCORDING TO THE TEAM THEY HAD A RUNTHROUGH WIRE TIP BREAKOFF DURING A PROCEDURE . THE PATIENT REMAINED STABLE DURING THE PROCEDURE AND NO HARM TO THE PATIENT WAS DONE. THE DOCTOR WAS PLACING A STENT IN A HEAVY CALICIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). HE HAD A RUNTHROUGH NS WIRE DOWN THE LAD AND A SION BLUE WIRE DOWN THE DIAG. THE SION BLUE WIRE WAS PULLED BACK BEFORE STENT DEPLOYMENT. ONCE STENT (BOSTON SCIENTIFIC SYNERGY) WAS DEPLOYED AND VESSEL WAS POST DILATED ( BOSTON EMERGE) THE RUNTHROUGH WIRE WAS REMOVED . UPON REMOVING THE TIP OF THE WIRE CAME OFF IN THE LEFT MAIN. THE DECISION WAS MADE TO PIN THE WIRE TO WALL WITH AN ADDITIONAL STENT (BOSTON SCIENTIFIC MEGATRON). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. A CORONARY ARTERY STENTING AND ANGIOPLASTY WAS REQUIRED TO TRAP THE WIRE TIP IN A SECURE LOCATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19544602 ↗
• InjuryMay 14, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE WIRE TIP BROKE OFF DURING THE CASE. IT IS POSSIBLE THAT THE TIP OF THE WIRE WAS CAUGHT ON A STENT STRUT OR WAS BEHIND THE STENT WHEN THE WIRE WAS REMOVED. THE WIRE TIP WAS LEFT IN THE PATIENT. THE TYPE OF PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA RIGHT RADIAL ACCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 16APR2024: THE WIRE WAS NOT RETRIEVED AS IT WAS DEEMED TOO RISKY. ADDITIONAL INFORMATION WAS RECEIVED ON 24APR2024: THERE ARE NO PLANS ON COLLECTING THE BROKEN PIECE FROM THE PATIENT. PATIENT WAS STABLE. TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4) ON 03MAY2024. THE EVENT DESCRIPTION STATES: "MIDDLE-AGED MALE WITH RECENT HISTORY OF CHEST PAIN. PROCEDURE: CARDIAC CATHETERIZATION WITH STENT. DURING THE PROCEDURE, THE TERUMO RUNTHROUGH WIRE TIP BROKE IN THE VESSEL. THE TIP IS RETAINED IN THE NATIVE LAD (LEFT ANTERIOR DESCENDING ARTERY). THE TIP WAS LEFT IN BY DECISION. NO KNOWN HARM TO PATIENT AT THIS TIME. PATIENT DISCHARGED THE NEXT DAY."

  Patient problems: Foreign Body In Patient

  MAUDE report 19309951 ↗
• InjuryMar 18, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A CARDIAC CATHETERIZATION INTERVENTIONAL CARDIOLOGY PROCEDURE, THE TIP OF THE INVOLVED RUNTHROUGH NS BROKE OFF AND WAS LEFT BEHIND IN THE PATIENT'S CORONARY ARTERY. NO FURTHER INTERVENTION WAS PERFORMED, AND THE PATIENT WAS STABLE. NO BLOOD LOSS WAS REPORTED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 29 FEB 2024: OTHER DEVICES USED INCLUDED THREE (3) DIFFERENT PCA BALLOONS (2.0X15, 1.0X10, 2.0X8NC) TIG CATHETER, EBU CATHETER, WIRE EXTENSION, TURNPIKE CATHETER, AND 2.25X18 DRUG ELUDING STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18923783 ↗
• InjuryMar 18, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A CARDIAC CATHETERIZATION INTERVENTIONAL CARDIOLOGY PROCEDURE, THE TIP OF THE INVOLVED RUNTHROUGH NS BROKE OFF AND WAS LEFT BEHIND IN THE PATIENT'S CORONARY ARTERY. NO FURTHER INTERVENTION WAS PERFORMED, AND THE PATIENT WAS STABLE. NO BLOOD LOSS WAS REPORTED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 29 FEB 2024: OTHER DEVICES USED INCLUDED THREE (3) DIFFERENT PCA BALLOONS (2.0X15, 1.0X10, 2.0X8NC) TIG CATHETER, EBU CATHETER, WIRE EXTENSION, TURNPIKE CATHETER, AND 2.25X18 DRUG ELUDING STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18923692 ↗
• InjuryJan 26, 2024Break; Difficult to Remove; Break; Difficult to Remove

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5148704. THE EVENT DESCRIPTION STATES THAT DURING HEART CATHETERIZATION, ATTEMPTED TO WITHDRAW THE RUNTHROUGH WIRE FROM THE RIGHT CORONARY ARTERY AND THE TIP OF THE WIRE BROKE. ATTEMPTED TO WITHDRAW WIRE WITH SECOND PROCEDURE BUT UNSUCCESSFUL. THE WIRE WAS IN A LOCATION THAT WOULD NOT MIGRATE. THE PATIENT WAS PLACED ON ANTICOAGULANTS AND SCHEDULED FOR OUTPATIENT PROCEDURE, IN FOLLOW UP TO REMOVE STENT/WIRE AND TO REPLACE THE STENT. THE DEVICE WAS EMBEDDED IN TISSUE OR PLAQUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18585710 ↗
• MalfunctionJan 3, 2024Entrapment of Device; Entrapment of Device

  THE USER FACILITY REPORTED THE RUN-THROUGH WIRE BECAME STUCK IN THE DISTAL PORTION OF A VERY CALCIFIED RIGHT CORONARY ARTERY. IT TOOK A FEW HOURS TO RELEASE THE WIRE FROM THE CORONARY ARTERY. THE PROCEDURE PERFORMED WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. THERE WAS NO INJURY TO THE PATIENT/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437580 ↗
• InjuryNov 30, 2023Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE TIP OF THE RUN-THROUGH WIRE FRACTURED OFF AND REMAINED IN THE VESSEL. THE PATIENT WAS STABLE THROUGHOUT; HOWEVER, THE PATIENT BECAME INCREASINGLY ANXIOUS. ANESTHESIA WAS INVOLVED AND THE WIRE WAS ABLE TO BE RETRIEVED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT CONDITION WAS GOOD. THE OUTCOME OF THE PROCEDURE WAS GOOD. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION INVOLVED. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18239440 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THEY EXPERIENCED DISTAL PERFORATION RELATED TO THE WIRE. THE PATIENT WAS SENT TO CARDIAC SURGERY FOR REPAIR. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 09 MAR 2023: THE PATIENT DID FINE AFTER THE SURGICAL INTERVENTION.

  Patient problems: Perforation

  MAUDE report 18238937 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE INTERVENTIONAL CARDIOLOGIST EXPERIENCED WIRE PERFORATION DURING A CORONARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 21NOV2023: THE PROCEDURE PERFORMED WAS A CIRCUMFLEX PERCUTANEOUS CORONARY INTERVENTION (PCI). THE DOCTOR REPORTED THAT WHILE SHAPING THE WIRE, HE HEARD AND FELT A CLICK DURING SHAPING OF THE WIRE TIP.

  Patient problems: Perforation

  MAUDE report 18190994 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE INTERVENTIONAL CARDIOLOGIST EXPERIENCED WIRE PERFORATION DURING A CORONARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE PROCEDURE PERFORMED WAS A CIRCUMFLEX PERCUTANEOUS CORONARY INTERVENTION (PCI). THE DOCTOR REPORTED THAT WHILE SHAPING THE WIRE, HE HEARD AND FELT A CLICK DURING SHAPING OF THE WIRE TIP.

  Patient problems: Perforation

  MAUDE report 18190904 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE INTERVENTIONAL CARDIOLOGIST EXPERIENCED WIRE PERFORATION DURING A CORONARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 21NOV2023: THE PROCEDURE PERFORMED WAS A LEFT ANTERIOR DESCENDING (LAD) PERCUTANEOUS CORONARY INTERVENTION (PCI). WHILE SHAPING THE RUN THROUGH WIRE, THE DOCTOR HEARD AN AUDIBLE CLICK; HOWEVER, HE PROCEEDED WITH THE WIRE FOR THE CASE AND THE RESULT WAS A PERFORATION.

  Patient problems: Perforation

  MAUDE report 18190733 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE INTERVENTIONAL CARDIOLOGIST EXPERIENCED WIRE PERFORATION DURING A CORONARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 21NOV2023: THE PROCEDURE PERFORMED WAS A LEFT ANTERIOR DESCENDING (LAD) PERCUTANEOUS CORONARY INTERVENTION (PCI). WHILE SHAPING THE RUN THROUGH WIRE, THE DOCTOR HEARD AN AUDIBLE CLICK; HOWEVER, HE PROCEEDED WITH THE WIRE FOR THE CASE AND THE RESULT WAS A PERFORATION.

  Patient problems: Perforation

  MAUDE report 18190705 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT ON 10OCT2023, DURING A CONVERSATION WITH AN INTERVENTIONAL CARDIOLOGY FELLOW DOCTOR, IT WAS MENTIONED THAT TWO MONTHS AGO THERE WAS A PERFORATION CAUSED BY THE RUNTHROUGH GUIDEWIRE INVOLVED. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: Perforation

  MAUDE report 18048206 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT ON (B)(6) 2023, DURING A CONVERSATION WITH AN INTERVENTIONAL CARDIOLOGY FELLOW DOCTOR, IT WAS MENTIONED THAT TWO MONTHS AGO THERE WAS A PERFORATION CAUSED BY THE RUNTHROUGH GUIDEWIRE INVOLVED. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: Perforation

  MAUDE report 18048200 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT ON (B)(6) 2023, DURING A CONVERSATION WITH AN INTERVENTIONAL CARDIOLOGY FELLOW DOCTOR, IT WAS MENTIONED THAT TWO MONTHS AGO THERE WAS A PERFORATION CAUSED BY THE RUNTHROUGH GUIDEWIRE INVOLVED. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: Perforation

  MAUDE report 18047234 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT ON (B)(6) 2023, DURING A CONVERSATION WITH AN INTERVENTIONAL CARDIOLOGY FELLOW DOCTOR, IT WAS MENTIONED THAT TWO MONTHS AGO THERE WAS A PERFORATION CAUSED BY THE RUNTHROUGH GUIDEWIRE INVOLVED. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: Perforation

  MAUDE report 18047223 ↗
• InjuryJul 28, 2023Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5118693. THE EVENT DESCRIPTION STATES: "DURING PCI (PERCUTANEOUS CORONARY INTERVENTION CATHETER) CATH INTERVENTIONAL WIRE TIP BROKE OFF AND WAS LEFT IN PATIENT'S CIRCUMFLEX ARTERY. ATTEMPTS TO REMOVE UNSUCCESSFUL." ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: LENGTH OF WIRE THAT BROKE OFF AND WAS LEFT WITHIN PATIENT ANATOMY WAS APPROXIMATELY 3 CM. THE PATIENT CONDITION WAS STABLE. THEY ATTEMPTED TO SNARE THE WIRE THAT BROKE OFF. THERE IS NO PLAN TO REMOVE THE REMAINING WIRE FRAGMENT FROM THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17420699 ↗
• InjuryJul 28, 2023Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5118693. THE EVENT DESCRIPTION STATES: "DURING PCI (PERCUTANEOUS CORONARY INTERVENTION CATHETER) CATH INTERVENTIONAL WIRE TIP BROKE OFF AND WAS LEFT IN PATIENT'S CIRCUMFLEX ARTERY. ATTEMPTS TO REMOVE UNSUCCESSFUL." ADDITIONAL INFORMATION WAS RECEIVED ON 13JUL2023: LENGTH OF WIRE THAT BROKE OFF AND WAS LEFT WITHIN PATIENT ANATOMY WAS APPROXIMATELY 3 CM. THE PATIENT CONDITION WAS STABLE. THEY ATTEMPTED TO SNARE THE WIRE THAT BROKE OFF. THERE IS NO PLAN TO REMOVE THE REMAINING WIRE FRAGMENT FROM THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17420488 ↗