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

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04987350744340), received between May 3, 2024 and Jul 27, 2026 — classified as 2 deaths, 23 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (18 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• DeathJul 27, 2026Material Fragmentation

  Terumo received the following information: It was reported that during percutaneous coronary intervention (PCI) the wire upon removal became entrapped by the stent placed in the distal left anterior descending artery (LAD) and was frayed. A portion of wire remained entrapped in the patient. There was no blood loss.Terumo Medical Corporation received an FDA MedWatch Report on (b)(6) 2026. The event description states: "Patient had heart failure, and had an impella placed in operating room prior to planned coronary angiogram for high risk cornary artery disease.In the cardiac cath lab, during angiogram, the Runthrough white wire, upon removal, became entrapped by the stent placed in the distal left anterior descending artery and was frayed. A portion of the wire remained entrapped in the patient. Retained wire was removed from patient. Wire fracture with retained wire in the LM (Left Main Coronary Artery) into LAD (Left Anterior Descending Artery), some of the wire able to be snared with filament protruding still into the aorta."Additional information was received on 30Jun2026: The wire became entrapped in the distal edge of the distal edge of the stent and became uncoiled upon attem

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 50036062 ↗
• MalfunctionJul 9, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25765841 ↗
• DeathJun 30, 2026

  PATIENT HAD HEART FAILURE, AND HAD AN IMPELLA PLACED IN OR PRIOR TO PLANNED CORONARY ANGIOGRAM FOR HIGH RISK CORONARY ARTERY DISEASE. IN THE CARDIAC CATH LAB, DURING ANGIOGRAM, THE RUN THROUGH WHITE WIRE, UPON REMOVAL, BECAME ENTRAPPED BY THE STENT PLACED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY AND WAS FRAYED. A PORTION OF THE WIRE REMAINED ENTRAPPED IN THE PATIENT. RETAINED WIRE WAS REMOVED FROM PATIENT. WIRE FRACTURE WITH RETAINED WIRE IN THE LM (LEFT MAIN CORONARY ARTERY) INTO LAD (LEFT ANTERIOR DESCENDING ARTERY), SOME OF THE WIRE ABLE TO BE SNARED WITH FILAMENT PROTRUDING STILL INTO THE AORTA. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, RUN THROUGH (PER SITE REPORTER).

  Patient problems: Foreign Body In Patient; Unspecified Heart Problem

  MAUDE report 25664207 ↗
• InjuryNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6). DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524372 ↗
• MalfunctionNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524370 ↗
• InjuryNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6). DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524149 ↗
• MalfunctionNov 11, 2025Break; Break

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DOCTOR STATED WHEN HE SHAPED THE WIRE THE TIP FEELS LIKE IT BREAKS OR WAS BROKEN. THE TYPE OF PROCEDURE WAS A LEFT HEART CATHETERIZATION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 27OCT2025: THE FIELD CLINICAL SPECIALIST (FCS) WAS PRESENT FOR THE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE DOCTOR COMMENTED THAT THE WIRE TIP SEEMED BROKEN WHEN HE WENT TO SHAPE IT. THERE WAS NO HARM CAUSED TO THE PATIENT. THE TIP DID NOT SEPARATE FROM THE WIRE HOWEVER IT DOES FEEL LIKE IT WAS BROKEN. WHEN WAS SHAPED THE WIRE INSTEAD OF THE TIP REPLICATING A NICE CURVE, IT SEEMED TO KINK OR BREAK AT ONE POINT. ADDITIONAL INFORMATION WAS RECEIVED ON 31OCT2025: THE DOCTOR STATED THAT HE HAS NOTICED THIS LATELY WITH THE TIP.

  Patient problems: Insufficient Information

  MAUDE report 23524147 ↗
• InjuryOct 22, 2025Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT "THE DATE OF EVENT IS AUGUST 2025. THE WIRE FRACTURED IN THE CORONARY ARTERY. ATTEMPTED REMOVAL OF WIRE, APPROXIMATELY 10 MM OF WIRE LEFT IN VESSEL. PATIENT HAD NO CHEST PAIN AND HEMODYNAMICALLY STABLE WHEN PROCEDURE WAS COMPLETED. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION." ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: ALL KNOWN INFORMATION WAS REPORTED TO MEDSUN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23359033 ↗
• InjuryOct 22, 2025Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT "THE DATE OF EVENT IS AUGUST 2025. THE WIRE FRACTURED IN THE CORONARY ARTERY. ATTEMPTED REMOVAL OF WIRE, APPROXIMATELY 10 MM OF WIRE LEFT IN VESSEL. PATIENT HAD NO CHEST PAIN AND HEMODYNAMICALLY STABLE WHEN PROCEDURE WAS COMPLETED. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION." ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: ALL KNOWN INFORMATION WAS REPORTED TO MEDSUN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23357754 ↗
• InjurySep 16, 2025Fracture; Material Frayed; Fracture; Material Frayed

  TERUMO MEDICAL RECEIVED A REPORT INVOLVING A WIRE MALFUNCTION DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE RTNS WIRE WAS POSITIONED IN A BRANCH VESSEL. UPON REMOVAL, THE WIRE BEGAN TO FRAY, AND A WIRE FRACTURE OCCURRED. THE WIRE WAS NOT TRAPPED BEHIND A STENT OR ANY OTHER OBSTRUCTION. MOST OF THE FRACTURED WIRE WAS SUCCESSFULLY SNARED AND REMOVED. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT REMAINED STABLE AND RECOVERED FROM THE PROCEDURE. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 21 AUG 2025: THE ISSUE BECAME APPARENT UNDER FLUOROSCOPY WHILE ATTEMPTING TO RETRACT THE WIRE. NO TESTING WAS PERFORMED. A PORTION OF THE WIRE REMAINS IN THE PATIENT'S LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO FURTHER ATTEMPTS WILL BE MADE TO RETRIEVE THE REMAINING WIRE. THE SAMPLE IS CONTAMINATED WITH BLOOD AND BODY FLUID BUT IS NOT CONTAMINATED WITH INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23069843 ↗
• InjurySep 16, 2025Fracture; Material Frayed; Fracture; Material Frayed

  TERUMO MEDICAL RECEIVED A REPORT INVOLVING A WIRE MALFUNCTION DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE RTNS WIRE WAS POSITIONED IN A BRANCH VESSEL. UPON REMOVAL, THE WIRE BEGAN TO FRAY, AND A WIRE FRACTURE OCCURRED. THE WIRE WAS NOT TRAPPED BEHIND A STENT OR ANY OTHER OBSTRUCTION. MOST OF THE FRACTURED WIRE WAS SUCCESSFULLY SNARED AND REMOVED. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT REMAINED STABLE AND RECOVERED FROM THE PROCEDURE. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 21 AUG 2025: THE ISSUE BECAME APPARENT UNDER FLUOROSCOPY WHILE ATTEMPTING TO RETRACT THE WIRE. NO TESTING WAS PERFORMED. A PORTION OF THE WIRE REMAINS IN THE PATIENT'S LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO FURTHER ATTEMPTS WILL BE MADE TO RETRIEVE THE REMAINING WIRE. THE SAMPLE IS CONTAMINATED WITH BLOOD AND BODY FLUID BUT IS NOT CONTAMINATED WITH INFECTIOUS AGENTS OR ANTI-CANCER AGENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23069842 ↗
• InjurySep 2, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  THE USER FACILITY REPORTED THAT DURING A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) IN A VERY TORTUOUS OM BRANCH OF THE CIRCUMFLEX ARTERY. THERE WAS NO TROUBLE GETTING THE RUN-THROUGH WIRE DOWN PAST THE AREA OF INTEREST WITH A "SAFETY LOOP" ALTHOUGH IT DID STRAIGHTEN OUT A VERY SIGNIFICANT LOOP IN THE ARTERY. WHEN THE PHYSICIAN TRIED TO PULL THE RUN-THROUGH WIRE BACK, HE STATED THAT THE WIRE "WAS STUCK". HE DID NOT PULL HARD; HOWEVER, DID SOME GENTLE TUGGING ON THE WIRE A COUPLE TIMES AND THE WIRE ENDED UP BREAKING OFF INSIDE THE CORONARY ARTERY. WE WERE UNABLE TO RETRIEVE THE DISTAL END OF THE WIRE, AND THE PATIENT WAS NOT A SURGICAL CANDIDATE. THEREFORE, THE PHYSICIAN DECIDED TO PIN THE WIRE BY PLACING THREE (3) STENTS TO COVER THE WIRE FROM THE DISTAL PART OF THE ARTERY ALL THE WAY TO THE OSTIUM. THIS WAS AN OUTPATIENT PLANNED PCI. THE PATIENT WENT TO THE LAB STABLE, AND ALL VITALS WERE WITHIN NORMAL LIMITS. THE BLOOD LOSS WAS LESS THAN 250CC. THE REMAINING WIRE WAS WIPED CLEAN, THEN PLACED IN A BIOHAZARD BAG POST PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 15AUG2025: THE IMAGES WERE REVIEWED, WHICH DID DEMONSTRATE A HIGHLY TORTUOUS OM ARTERY. THE VESSEL WAS PERFOR

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 22940350 ↗
• InjurySep 2, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  THE USER FACILITY REPORTED THAT DURING A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) IN A VERY TORTUOUS OM BRANCH OF THE CIRCUMFLEX ARTERY. THERE WAS NO TROUBLE GETTING THE RUN-THROUGH WIRE DOWN PAST THE AREA OF INTEREST WITH A "SAFETY LOOP" ALTHOUGH IT DID STRAIGHTEN OUT A VERY SIGNIFICANT LOOP IN THE ARTERY. WHEN THE PHYSICIAN TRIED TO PULL THE RUN-THROUGH WIRE BACK, HE STATED THAT THE WIRE "WAS STUCK". HE DID NOT PULL HARD; HOWEVER, DID SOME GENTLE TUGGING ON THE WIRE A COUPLE TIMES AND THE WIRE ENDED UP BREAKING OFF INSIDE THE CORONARY ARTERY. WE WERE UNABLE TO RETRIEVE THE DISTAL END OF THE WIRE, AND THE PATIENT WAS NOT A SURGICAL CANDIDATE. THEREFORE, THE PHYSICIAN DECIDED TO PIN THE WIRE BY PLACING THREE (3) STENTS TO COVER THE WIRE FROM THE DISTAL PART OF THE ARTERY ALL THE WAY TO THE OSTIUM. THIS WAS AN OUTPATIENT PLANNED PCI. THE PATIENT WENT TO THE LAB STABLE, AND ALL VITALS WERE WITHIN NORMAL LIMITS. THE BLOOD LOSS WAS LESS THAN 250 CC. THE REMAINING WIRE WAS WIPED CLEAN, THEN PLACED IN A BIOHAZARD BAG POST PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 15AUG2025: THE IMAGES WERE REVIEWED, WHICH DID DEMONSTRATE A HIGHLY TORTUOUS OM ARTERY. THE VESSEL WAS PERFO

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 22939580 ↗
• InjuryAug 6, 2025Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT A PIECE OF THE DEVICE'S TIP BROKE OFF IN THE PATIENT'S AORTA. THE PROCEDURE PERFORMED WAS A CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: Foreign Body In Patient

  MAUDE report 22726016 ↗
• InjuryAug 6, 2025Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT A PIECE OF THE DEVICE'S TIP BROKE OFF IN THE PATIENT'S AORTA. THE PROCEDURE PERFORMED WAS A CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI).

  Patient problems: Foreign Body In Patient

  MAUDE report 22725999 ↗
• InjuryAug 4, 2025Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THEY HAD PERFORMED A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH PRE-DILITATION BALLOONING AND STENTING OF BOTH AN OM2 AND MID-CIRCUMFLEX. IT WENT SUCCESSFULLY AND THEY RE-POSITIONED THE RUNTHOUGH WIRE INTO OTHER VESSELS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DIAG AND PERFORMED BALLOONING AND STENTING TO THE OTHER VESSELS, ALSO SUCCESSFULLY AND UNEVENTFULLY. THEY THEN SAW A FLOW DEFECT IN THE OSTIAL/PROX OM2 STENTED AREA. THEY TURNED THEIR ATTENTION BACK TO THE OM2 AND RE-WIRED THE CIRC AND OM2 WHICH WAS THE STENTED PORTION. THEY PASSED A 2.5 X 6 BALLOON IN AN ATTEMPT TO BALLOON THE DEFECT; HOWEVER, THE BALLOON WOULD NOT ADVANCE TO THE LESION. AT THAT TIME THE WIRE COULD NOT BE REMOVED. DURING THE ATTEMPT TO REMOVE THE WIRE THE DISTAL TIP OF THE RUNTHOUGH WIRE BROKE OFF. IT DID NOT SEEM TO MIGRATE, AND THE FLOW DID NOT SEEM DISRUPTED. AN ATTEMPT WAS MADE TO PASS A STENT DOWN TO TRAP THE WIRE IN PLACE HOWEVER, THAT WAS UNSUCCESSFUL. THEY ENDED THE PROCEDURE AT THAT TIME. THE PATIENT WAS IN GOOD CONDITION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 16JUL2025: NO OTHER TERUMO PRODUCTS WERE USED IN COMBINATION WITH THE WIRE. THE

  Patient problems: Foreign Body In Patient

  MAUDE report 22709220 ↗
• InjuryAug 4, 2025Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THEY HAD PERFORMED A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH PRE-DILATATION BALLOONING AND STENTING OF BOTH AN OM2 AND MID-CIRCUMFLEX. IT WENT SUCCESSFULLY AND THEY RE-POSITIONED THE RUNTHOUGH WIRE INTO OTHER VESSELS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DIAG AND PERFORMED BALLOONING AND STENTING TO THE OTHER VESSELS, ALSO SUCCESSFULLY AND UNEVENTFULLY. THEY THEN SAW A FLOW DEFECT IN THE OSTIAL/PROX OM2 STENTED AREA. THEY TURNED THEIR ATTENTION BACK TO THE OM2 AND RE-WIRED THE CIRC AND OM2 WHICH WAS THE STENTED PORTION. THEY PASSED A 2.5 X 6 BALLOON IN AN ATTEMPT TO BALLOON THE DEFECT HOWEVER, THE BALLOON WOULD NOT ADVANCE TO THE LESION. AT THAT TIME THE WIRE COULD NOT BE REMOVED. DURING THE ATTEMPT TO REMOVE THE WIRE THE DISTAL TIP OF THE RUNTHOUGH WIRE BROKE OFF. IT DID NOT SEEM TO MIGRATE, AND THE FLOW DID NOT SEEM DISRUPTED. AN ATTEMPT WAS MADE TO PASS A STENT DOWN TO TRAP THE WIRE IN PLACE HOWEVER, THAT WAS UNSUCCESSFUL. THEY ENDED THE PROCEDURE AT THAT TIME. THE PATIENT WAS IN GOOD CONDITION. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 16JUL2025: NO OTHER TERUMO PRODUCTS WERE USED IN COMBINATION WITH THE WIRE. THE

  Patient problems: Foreign Body In Patient

  MAUDE report 22709219 ↗
• InjuryJul 10, 2025Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE DEVICE BROKE IN THE CASE. WHEN REMOVING THE WIRE, THE TIP BROKE OFF IN THE PATIENT, AND THEY COULD NOT RETRIEVE IT. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22468165 ↗
• InjuryJul 10, 2025Break; Material Separation; Break; Material Separation

  THE USER FACILITY REPORTED THAT THE DEVICE BROKE IN THE CASE. WHEN REMOVING THE WIRE, THE TIP BROKE OFF IN THE PATIENT, AND THEY COULD NOT RETRIEVE IT. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22468162 ↗
• MalfunctionApr 4, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A LEFT HEART CATHETERIZATION, THE WIRE CAME APART. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773353 ↗
• InjuryMar 19, 2025Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "STENT DEPLOYED, THE WIRE COILED ITSELF TO THE DISTAL END OF THE STENT AND COULD NOT BE REMOVED. PHYSICIAN ATTEMPTED TO DISLODGE THE WIRE TIP WITH OTHER INTERVENTIONAL WIRES AND MICROCATHETERS, BUT WAS UNSUCCESSFUL. ANOTHER PHYSICIAN SCRUBBED IN TO ASSIST BUT WAS ALSO UNABLE TO DISLODGE THE WIRE. CT SURGERY WAS CONSULTED. PATIENT REQUIRED SURGERY FOR REMOVAL OF WIRE."

  Patient problems: Foreign Body In Patient

  MAUDE report 21642964 ↗
• InjuryMar 19, 2025Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "STENT DEPLOYED, THE WIRE COILED ITSELF TO THE DISTAL END OF THE STENT AND COULD NOT BE REMOVED. PHYSICIAN ATTEMPTED TO DISLODGE THE WIRE TIP WITH OTHER INTERVENTIONAL WIRES AND MICROCATHETERS, BUT WAS UNSUCCESSFUL. ANOTHER PHYSICIAN SCRUBBED IN TO ASSIST BUT WAS ALSO UNABLE TO DISLODGE THE WIRE. CT SURGERY WAS CONSULTED. PATIENT REQUIRED SURGERY FOR REMOVAL OF WIRE."

  Patient problems: Foreign Body In Patient

  MAUDE report 21642963 ↗
• InjuryMar 19, 2025Material Separation; Migration; Material Separation; Migration

  THE USER FACILITY REPORTED THAT THE CATH LAB WAS PERFORMING A COMPLEX INTERVENTIONAL PROCEDURE AND HAD A TERUMO RUNTHROUGH INTERVENTIONAL WIRE FRACTURE WHILE IN THE PATIENT'S CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO SNARE AND RETRIEVE THE FRACTURED WIRE; HOWEVER, IT WAS UNSUCCESSFUL. THE WIRE REMAINED IN THE PATIENT'S CORONARY ARTERY AND, PER THE PHYSICIAN, WAS SANDWICHED IN BETWEEN THE OUTER STENT STRUTS AND THE CORONARY VESSEL WALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS IN GOOD CONDITION PER THE CARDIOLOGIST. AN RL WAS PLACED; HOWEVER, THE STAFF DID NOT RETAIN THE FRACTURED WIRE POST PROCEDURE, AND IT WAS DISCARDED BY ACCIDENT. THE DEVICE STICKERS FOR THE WIRE IN QUESTION WERE PLACED ON THE CHARGE SHEET AND THE ASSOCIATED INFORMATION WAS PROVIDED. THE LOCATION OF FRACTURED WIRE WAS IN THE 1ST DIAGONAL. FIVE RUNTHROUGH WIRES WERE OPENED AND USED FOR THE PROCEDURE (B)(6). AFTER SPEAKING TO THE PHYSICIANS, THEY BELIEVE THIS WAS NOT A PRODUCT ISSUE; HOWEVER, A PROCEDURAL COMPLICATION DUE TO THE IN THE DIAGONAL WIRE GETTING STUCK ON THE LAD STENT DURING A DK CRUSH. NO BLOOD LOSS WAS REPORTED. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21642650 ↗
• InjuryMar 19, 2025Material Separation; Migration; Material Separation; Migration

  THE USER FACILITY REPORTED THAT THE CATH LAB WAS PERFORMING A COMPLEX INTERVENTIONAL PROCEDURE AND HAD A TERUMO RUN THROUGH INTERVENTIONAL WIRE FRACTURE WHILE IN THE PATIENT'S CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO SNARE AND RETRIEVE THE FRACTURED WIRE; HOWEVER, IT WAS UNSUCCESSFUL. THE WIRE REMAINED IN THE PATIENT'S CORONARY ARTERY AND, PER THE PHYSICIAN, WAS SANDWICHED IN BETWEEN THE OUTER STENT STRUTS AND THE CORONARY VESSEL WALL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS IN GOOD CONDITION PER THE CARDIOLOGIST. AN RL WAS PLACED; HOWEVER, THE STAFF DID NOT RETAIN THE FRACTURED WIRE POST PROCEDURE, AND IT WAS DISCARDED BY ACCIDENT. THE DEVICE STICKERS FOR THE WIRE IN QUESTION WERE PLACED ON THE CHARGE SHEET AND THE ASSOCIATED INFORMATION WAS PROVIDED. THE LOCATION OF FRACTURED WIRE WAS IN THE 1ST DIAGONAL. FIVE RUN THROUGH WIRES WERE OPENED AND USED FOR THE PROCEDURE 240613Y X1 AND 240708Y X4. AFTER SPEAKING TO THE PHYSICIANS, THEY BELIEVE THIS WAS NOT A PRODUCT ISSUE; HOWEVER, A PROCEDURAL COMPLICATION DUE TO THE IN THE DIAGONAL WIRE GETTING STUCK ON THE LAD STENT DURING A DK CRUSH. NO BLOOD LOSS WAS REPORTED. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21642513 ↗
• MalfunctionJan 6, 2025

  DURING A RADIOFREQUENCY CATHETER ABLATION, WE WERE UNABLE TO PASS BALLOONS. WE TRIED MULTIPLE TIMES WITH MULTIPLE BALLOONS AND GUIDES. THERE WAS RESISTANCE FELT AT A USUAL SPOT IN THE GUIDE CATHETER. WIRE WAS REMOVED AND WIPED AND REINSERTED. AFTER ABORTING THE PROCEDURE AND INSPECTING THE RUN THROUGH .014 X 180CM INTERVENTION WIRE IT WAS FOUND THAT AT A TRANSITION POINT ON THE WIRE WAS WHERE EVERYTHING WAS GETTING STUCK. THIS WAS TESTED WITH SEVERAL BALLOONS, AND THEY ALL GOT STUCK. WE TRIED A NEW WIRE AND FOUND THAT ALTHOUGH THE TRANSITION POINT COULD BE FELT BALLOONS CROSSED FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078606 ↗