Fighter™ H749393031900Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729887676), received between Nov 22, 2016 and Apr 25, 2023 — classified as 1 death, 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT AND PERFORATION OCCURRED. THE PATIENT WAS PRESENTED WITH CHRONIC TOTAL OCCLUSION (CTO) AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID TO DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 190CM, STRAIGHT-TIP FIGHTER GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION, THE WIRE WAS LODGED IN THE CALCIUM. WHEN AN ATTEMPT WAS MADE TO PULL BACK THE WIRE, THE TIP CAME OFF AND COULD NOT BE RECOVERED. THE RADIOPAQUE PORTION OF THE WIRE WAS LEFT IN THE BODY BUT WAS SECURED BETWEEN THE VESSEL AND THE CALCIUM. IT WAS THEN NOTED THAT PERFORATION OCCURRED IN THE SEPTAL BRANCH OF THE LAD. SUBSEQUENTLY, STAT ECHOCARDIOGRAM AND FINAL ANGIOGRAM WERE PERFORMED TO ENSURE THE PERFORATION WAS CONTAINED. THE PROCEDURE WAS NOT COMPLETED AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AND WAS FULLY RECOVERED POST PROCEDURE.

  Patient problems: Foreign Body In Patient; Perforation

  MAUDE report 16808582 ↗
• MalfunctionSep 30, 2022Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM, STRAIGHT-TIP FIGHTER GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, A BREAKAGE IN THE DEVICE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510453 ↗
• InjuryOct 26, 2021Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHED AND REMAINED IN THE PATIENT. THE PATIENT PRESENTED OR A PERCUTANEOUS CORONARY INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING ARTERY. A FLEXIBLE METAL 6F GUIDE CATHETER WAS ADVANCED AND THE LEFT CORONARY ARTERY WAS CANNULATED. A 190CM, STRAIGHT-TIP FIGHTER GUIDEWIRE WAS ADVANCED ON THIS HIGH SUPPORT CORONARY ANGIOPLASTY GUIDE POSITIONING IT AGAINST THE TOTAL OCCLUSION BUT AFTER SEVERAL ATTEMPTS THE DEVICE COULD NOT CROSS THE LESION. TO OPTIMIZE SUPPORT, A 2.00 X 8MM CORONARY ANGIOPLASTY BALLOON WAS POSITIONED IN FRONT OF THE LESION AND TORQUE MOVEMENTS WERE PERFORMED IN THE ANGIOPLASTY GUIDE, MAKING IT ADVANCE TO THE MIDDLE SEGMENT. THE DISTAL END OF THE GUIDE FRACTURED AND WAS LODGED INTRAVENOUSLY BY THE TISSUE OF THE TOTAL OCCLUSION. THERE WAS NO EVIDENCE OF DISSECTION OR RUPTURE OF THE VESSEL. THE PATIENT WAS ASYMPTOMATIC AND HEMODYNAMICALLY STABLE SO FACED WITH FAILURE OF THE PERCUTANEOUS STRATEGY, THE PROCEDURE WAS CANCELLED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12698504 ↗
• InjuryMar 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE FRACTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 190CM, STRAIGHT-TIP FIGHTER GUIDE WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE WIRE BROKE FROM THE DISTAL TIP TO THE PROXIMAL RADIOPAQUE. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474761 ↗
• MalfunctionFeb 2, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 190CM, STRAIGHT-TIP FIGHTER GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, UPON UNPACKING, THE GUIDEWIRE BENT AND THE GUIDEWIRE TIP FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268177 ↗
• InjuryJun 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY WHICH WAS FULLY STENTED. THE OCCLUSION WAS AT THE PROXIMAL END OF THE STENT. A 190CM, STRAIGHT-TIP FIGHTER GUIDEWIRE WAS ADVANCED WITH A TURNPIKE IN AN ATTEMPT TO CROSS THE LESION; HOWEVER, THE TIP OF THE WIRE SHEARED OFF. THE DETACHED TIP WAS SUCCESSFULLY REMOVED BY TRAPPING THE TIP OF THE WIRE INSIDE THE GUIDE WITH A BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. ADDITIONAL WIRES WERE ATTEMPTED TO BE USED, BUT THE PROCEDURE WAS UNSUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 10106207 ↗
• InjuryFeb 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DISTAL TIP DETACHMENT OCCURED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX. A 190CM FIGHTER WAS ADVANCED TO TREAT THE LESION. THE DEVICE WAS CROSSED THROUGH THE TOTALLY OCCLUDED LESION AND EMBEDDED IN THE CALCIUM. WHEN THE TURNPIKE WAS ADVANCED OVER THE WIRE FOR EXCHANGE, THEY THE PULLED THE WIRE BACK AND 4 CM OF THE TIP BROKE OFF. THE WIRE REMAINED IN THE PATIENT'S BODY. NO PATIENT COMPLICATION WERE REPORTED. THE NEXT DAY, A NEW WIRE WAS PLACED NEXT THE DETACHED COMPONENT AND A STENT WAS DEPLOYED TO TRAP THE WIRE. THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY ISSUE TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS LODGED IN THE DISTAL CIRCMFLEX AND THEY COULD NEVER GET BACK TO IT THROUGH ANTEGRADE APPROACH. THEY WENT TO RETROGRADE AND EXTERNALIZED THE WIRE AND ATTEMPTED THE CIRCUMFLEX TRAPPING THE WIRE.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism; Numbness; Stroke/CVA

  MAUDE report 8327836 ↗
• DeathJul 5, 2017Fracture; Fracture

  SAME CASE AS MDR ID: 22134265-2017-06938, 134265-2017-06679, AND 2134265-2017-06948. IT WAS REPORTED THAT GUIDEWIRE FRACTURE, VESSEL OCCLUSION, MYOCARDIAL INFARCTION AND DEATH OCCURRED. THE PATIENT PRESENTED WITH OSTIAL CIRCUMFLEX (CX) DISEASE. A FIGHTER GUIDEWIRE WAS ADVANCED INTO THE VESSEL. A 3.0X20MM SYNERGY DRUG ELUTING STENT WAS ADVANCED AND DEPLOYED IN THE LEFT MAIN (LM) ARTERY INTO THE CX. AN 8F GUIDE CATHETER WAS ADVANCED FURTHER INTO THE VESSEL AND SUBSEQUENTLY LONGITUDINALLY DEFORMED THE DEPLOYED 3.0X20MM SYNERGY STENT. THE DEFORMED STENT TRAPPED THE FIGHTER GUIDEWIRE IN THE STENT STRUCTURE. SUBSEQUENTLY THE FIGHTER GUIDEWIRE FRACTURED. THE TRAPPED PORTION REMAINED IN THE VESSEL. TWO SYNERGY STENTS SIZES 3.0X12MM AND 4.0X16MM WERE DEPLOYED IN THE VESSEL TO COVER THE DEFORMED STENT. THE PROCEDURE ENDED AND PATIENT LEFT THE CATHETERIZATION LAB WITHOUT FURTHER COMPLICATION. EIGHT DAYS LATER THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT OF ANOTHER HOSPITAL WITH AN ACUTE ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). ANGIOGRAPHY REVEALED THE LM HAD CLOSED OFF IN THE MID SEGMENT. THERE WAS NO VISUALIZATION OF THE LEFT ANTERIOR DESCENDING (LAD) OR CX ARTERIES. THE TYPE

  Patient problems: Death; Myocardial Infarction; ST Segment Elevation

  MAUDE report 6686132 ↗
• MalfunctionMar 16, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTIOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. FOUR BALLOON CATHETERS HAD BEEN DELIVERED OVER THE 190CM FIGHTER GUIDEWIRE AND CROSSED THE LESION SUCCESSFULLY, BUT WERE NOT ABLE TO OPEN THE LESION. THEN A NON-BSC BALLOON CATHETER WAS USED AND INFLATED PAST RATED BURST PRESSURE FOR FOUR OR FIVE TIMES. WHILE TRYING TO REMOVE THE BALLOON IT BECAME TEMPORARILY STUCK ON THE GUIDEWIRE. THE PHYSICIAN ¿TORTURED¿ THE BALLOON WHICH MAY HAVE BEEN THE REASON FOR IT NOT SLIDING OFF THE WIRE EASILY. THE BALLOON CATHETER WAS PULLED OUT WITH THE GUIDEWIRE TOGETHER. ONCE THE DEVICES WERE TAKEN OUT, THE BALLOON CATHETER WAS REMOVED FROM THE GUIDEWIRE EASILY. DUE TO THE COMPLEXITY OF THE LESION IT WAS DECIDED TO REASSESS THE PLAN TO OPEN THIS LESION AND THE PROCEDURE WAS FINISHED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6411010 ↗
• InjuryNov 22, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT TIP DETACHMENT INSIDE THE PATIENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA AN ANTEGRADE APPROACH. THE AMBIGUOUS CAP LESION WAS LOCATED IN THE CALCIFIED, CHRONIC TOTAL OCCLUSION RIGHT CORONARY ARTERY (RCA). A 190CM FIGHTER GUIDEWIRE WAS ENGAGED TO THE LESION. THE PHYSICIAN ATTEMPTED TO "KNUCKLE" THE GUIDEWIRE VERY AGGRESSIVELY WITH A NON-BSC CATHETER FOR SUPPORT. THE TIP OF THE GUIDEWIRE DETACHED AND REMAINED IN THE MID RCA. THE REST OF THE WIRE WAS REMOVED FROM THE BODY. THE DETACHED TIP WAS ATTEMPTED TO BE REMOVED WITH THE SUPPORT OF A 2.5X20MM EMERGE BALLOON CATHETER WITHOUT SUCCESS. A 3.5X15 NC EMERGE WAS INFLATED AT THE MID RCA WHERE THE FIGHTER WAS LOCATED AND A 3.5X38 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED OVER THE BROKEN FIGHTER TIP. IT APPEARED THAT THE SYNERGY STENT COMPLETELY "TRAPPED" THE WIRE TIP AGAINST THE VESSEL WALL AS THERE WERE NO LUMINAL IRREGULARITIES IN THE POST IMAGES. AT THE END OF THE CASE THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6121132 ↗