Samurai™ H749393021900Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729887829), received between Jan 11, 2017 and Oct 22, 2025 — classified as 1 death, 14 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 38 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE AND REMOVAL DIFFICULTY OCCURRED. THE DIFFUSELY STENOSED TARGET LESION OF LESS THAN 30% WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER WITHDRAWAL OF A BALLOON, THE 190CM STRAIGHT-TIP SAMURAI GUIDEWIRE WAS NOTED TO BE ABNORMAL AND COULD NOT BE WITHDRAWN. A MICROCATHETER WAS INTRODUCED, BUT THE GUIDEWIRE WAS FRACTURED AND COULD NOT BE REMOVED. THE DEVICE FRAGMENT REMAINS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23360676 ↗
• MalfunctionAug 7, 2025Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN OBJECT WAS PRESENT WHICH LEADS TO A DEVICE CONTAMINATION. DURING PREPARATION AND PRIOR TO OPENING THE PACKAGE OF A 190 CM SAMURAI GUIDEWIRE, A FOREIGN OBJECT WAS OBSERVED INSIDE THE PACKAGING AND COMPROMISED THE STERILITY OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745604 ↗
• MalfunctionJun 5, 2025Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12MAY2025. IT WAS REPORTED THAT A GUIDEWIRE KINKED OCCURRED. A PERCUTANEOUS INTERVENTION PROCEDURE WAS BEING PERFORMED. A 190CM SAMURAI GUIDEWIRE WAS USED. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE GUIDEWIRE WAS ALREADY KINKED OR BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DISTAL TIP AND CORE WIRE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150939 ↗
• MalfunctionMay 12, 2025Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-APR-2025. IT WAS REPORTED THAT GUIDEWIRE TIP STRETCHED WAS ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM SAMURAI GUIDEWIRE WAS ADVANCED AND THE GUIDEWIRE WAS FOUND TO BE STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED CORE WIRE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003680 ↗
• MalfunctionNov 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. THE 83% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 190 CM STRAIGHT-TIP (5PK) WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE FRACTURED. THE DEVICE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT'S CONDITION REMAINED STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20593580 ↗
• MalfunctionSep 6, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED FOR A BIFURCATION PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE TARGET LESION WAS LOCATED IN A CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A NON-BOSTON SCIENTIFIC (NON-BSC) GUIDEWIRE WAS PLACED AND AN OPTICROSS HD VASCULAR IMAGING CATHETER WAS ADVANCED OVER A SAMURAI GUIDEWIRE FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE IMAGE DISAPPEARED. THE PULLBACK STOPPED AFTER APPROXIMATELY 4CM. THE PHYSICIAN ATTEMPTED TO BRING THE CATHETER BACK INTO STARTING POSITION, BUT IT DID NOT WORK, AND THE OPTICROSS CATHETER WAS STUCK WITH THE GUIDEWIRE. IT WAS NOTED THAT THE CATHETER LOOKED LIKE A CORKSCREW. EVERYTHING WAS REMOVED TOGETHER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH OTHER DEVICES. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158880 ↗
• MalfunctionJun 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING PEELING OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM SAMURAI GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE WAS PEELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637169 ↗
• InjuryMay 6, 2024Fracture; Difficult to Remove; Difficult to Advance; Fracture; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY AND SUBSEQUENT INTRAVASCULAR ULTRASOUND (IVUS)-GUIDED STENT IMPLANTATION IN THE 80% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ACCESS WAS GAINED IN THE RIGHT BRACHIAL ARTERY AND A SAMURAI GUIDEWIRE WAS SELECTED AND PLACED IN THE DISTAL SECTION OF THE LAD BRANCH. ANOTHER NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE WAS ADVANCED INTO THE DISTAL END OF THE SPIRAL BRANCH. IVUS WAS INSERTED FOR EXAMINATION AND THEN SAMURAI GUIDEWIRE COULD NOT BE MOVED FORWARD OR BACKWARD. UPON WITHDRAWAL OF THE SAMURAI GUIDEWIRE, PART OF IT REMAINED IN THE LEFT CORONARY ARTERY AND LEFT CORONARY SINUS. AN ATTEMPT TO USE THE NON-BSC GUIDEWIRE TO WRAP THE FRACTURED SAMURAI GUIDEWIRE FAILED. AN ADDITIONAL ACCESS SITE WAS THEN GAINED ON THE LEFT BRACHIAL ARTERY ALLOWING FOR AN ATTEMPT TO RETRIEVE THE FRACTURED GUIDE WIRE FROM THE LEFT CORONARY ARTERY USING A SNARE DEVICE, BUT IT WAS UNSUCCESSFUL. STENTS WERE SUCCESSFULLY IMPLANTED IN THE LAD ARTERY USING BALLOONS AND STENTS OF VARIOUS SIZES. THE IMPROVEMENT IN THE STENOTIC LESIONS WAS CONFIRMED THROUGH ANGIOGRAPHY AND IVUS. THE PRO

  Patient problems: Foreign Body In Patient

  MAUDE report 19255737 ↗
• InjuryJan 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING INTERVENTION. A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT BROKE OFF IN THE PATIENT'S BODY. THE REMAINING PIECE WAS RETRIEVED VIA SNARE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460683 ↗
• InjuryJan 5, 2024Entrapment of Device; Failure to Advance; Material Deformation; Entrapment of Device; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS ADVANCED FOR TREATMENT, HOWEVER, WHEN THE PHYSICIAN TRIED TO INSERT THE WIRE, IT FAILED TO CROSS AND STUCK IN THE LESION. A BOSTON SCIENTIFIC FIGHTER WIRE WAS INSERTED AND TWISTED WITH THE SAMURAI. THE WIRES WERE REMOVED TOGETHER, AND IT WAS NOTED THAT THE SAMURAI WIRE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451641 ↗
• MalfunctionNov 29, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-NOV-2023. IT WAS REPORTED THAT CROSSING DIFFICULTIES OCCURRED. THE TARGET LESION IS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT DISTAL TIP DETACHMENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231380 ↗
• MalfunctionOct 20, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND NON-TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY EXTENDING INTO THE FIRST OBTUSE MARGINAL BRANCH. THERE WAS ANGULATION INTO THE LCX. AFTER A SAMURAI GUIDE WIRE, ALONG WITH ANOTHER WIRE, WAS PLACED, A 2.50 MM X 12 MM EMERGE BALLOON CATHETER WAS ADVANCED ON THE SAMURAI. WHEN THE BALLOON WAS IN THE GUIDE CATHETER, IT GOT STUCK ON THE SAMURAI WIRE. IT WAS NOTED THAT THE WIRES WERE NOT CROSSED BUT THE BALLOON GOT STUCK MIDWAY IN THE GUIDE. THE EMERGE BALLOON AND SAMURAI WIRE REMAINED INTACT AND WERE REMOVED TOGETHER. THERE WAS NO VISIBLE DAMAGE TO THE EMERGE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980653 ↗
• InjurySep 11, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED, AND THE PATIENT WAS SENT FOR BYPASS SURGERY. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. A 190CM, STRAIGHT-TIP (5PK) SAMURAI WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN WIRED THE RIGHT CORONARY ARTERY (RCA) WITH THE SAMURAI PRIOR TO DILATING AND STENTING THE BLOCKAGE, THE WIRE BECAME STUCK IN A SMALL VESSEL, AND IT WOULD NOT RELEASE. THE GUIDEWIRE WAS ENTRAPPED IN THE ARTERY, AND IT APPEARED TO BE KNOTTED AND STRETCHED OUT. THE PATIENT WAS GIVEN NITROGLYCERIN TO SEE IF THE WIRE WOULD RELEASE BUT IT DID NOT. SINCE THERE WAS ALSO SIGNIFICANT DISEASE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THE PATIENT WAS SENT FOR CORONARY ARTERY BYPASS SURGERY (CABG) FOR THE BLOCKAGES AND GUIDEWIRE REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 17725917 ↗
• MalfunctionJul 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS MID RIGHT CORONARY ARTERY. A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE GUIDEWIRE WAS TWISTED AND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352281 ↗
• InjuryMar 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED FOR PROVISIONAL STENTING ACROSS THE LEFT MAIN (LM) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 60-70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. THE FIRST SAMURAI GUIDEWIRE CROSSED THE LAD AND THE SECOND SAMURAI THE LEFT CIRCUMFLEX ARTERY (LCX). A 3.5 SYNERGY MEGATRON STENT WAS DEPLOYED FROM THE LAD ACROSS THE LEFT MAIN (LM) AND AN AGENT DCB WAS DEPLOYED AT 6 ATMOSPHERES AT THE MID LCX. THE MEGATRON WAS THEN POST DILATED WITH A 4.00 X 8 NON-COMPLAINT (NC) BALLOON AT THE LAD AND A 4.50 X 8 NC BALLOON AT THE LM. THE VESSEL WAS EXAMINED USING AN OPTICROSS HD IMAGING CATHETER AND SINCE THE LM APPEARED TO BE AROUND 5.00MM, IT WAS POST-DILATED WITH A 5.00 X 8 NC BALLOON. THE OPTICROSS HD WAS USED AGAIN, AND THE PHYSICIAN WAS SATISFIED WITH THE RESULTS. THE PHYSICIAN DECIDED TO REMOVE THE SAMURAI WIRE FROM THE LCX BUT IT WAS SNAPPED AND 4CM REMAINED IN THE VESSEL. A NON-BOSTON SCIENTIFIC WIRE WAS INSERTED IN THE LCX AND A 2.00 EMERGE BALLOON ADVANCED IN AN ATTEMPT TO PULL OUT THE WIRE. THE SAMURAI REMAINED STUCK SO TWO STENTS, A 3.00 X 38 AND A 3.50 X 24, WERE IMPLANTED FROM

  Patient problems: Foreign Body In Patient

  MAUDE report 16535090 ↗
• InjuryMar 6, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE BREAK OCCURRED. A SAMURAI GUIDEWIRE WAS SELECTED FOR USE, AS THE PROCEDURE WAS FINISHING THE SAMURAI BROKE IN TWO PIECES. THE DETACHED SAMURAI GUIDEWIRE WAS RETRIEVED FROM THE VESSEL. THE PATIENT WAS STABLE, NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE SAMURAI GUIDEWIRE WAS LOCATED BETWEEN THE INTIMA OF THE VESSEL AND THE DRUG ELUTING STENT THAT WAS PREVIOUSLY PLACED. THE DETACHED WIRE WAS REMOVED BUT THE TIP REMAINED LOCKED WITH THE PREVIOUSLY IMPLANTED DRUG ELUTING STENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485370 ↗
• InjuryMar 15, 2022Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT AND FRACTURE OCCURRED WHILE THE FRACTURED FRAGMENT REMAINED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT CIRCUMFLEX (LCX) ARTERY WITH 80% PROXIMAL STENOSIS AND 50% MIDDLE STENOSIS. A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS PLACED IN AN OBTUSE MARGINAL (OM) FOR SIDE BRANCH PROTECTION FOR THE PLACEMENT OF TWO NON BOSTON SCIENTIFIC (BSC) STENTS. AFTER THE SECOND NON-BSC STENT WAS PLACED, WHEN EXTRACTING THE SAMURAI, IT GOT STUCK UNDER THE PROXIMAL STENT. THE PHYSICIAN THEN USED A NON-BSC BALLOON (1.0X8MM) TO PROTECT AND ATTEMPT TO REMOVE THE SAMURAI. THE SAMURAI THEN FRACTURED ABOUT 4CM FROM THE TIP, WHICH WAS NOT ABLE TO BE REMOVED. THEREFORE, THE PHYSICIAN THEN USED A BSC PROMUS PREMIER STENT TO PRESS THE FRACTURED SAMURAI FRAGMENT ON THE PATIENT VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13776507 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP FRACTURE OCCURRED. THE 90 DEGREE ANGLE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX. A 190CM SAMURAI GUIDEWIRE WAS ADVANCED, BUT THE TIP FRACTURED AFTER ADVANCEMENT PAST THE LESION. AN ATTEMPT TO SNARE THE FRACTURED TIP WITH A GOOSE NECK SNARE WAS MADE, BUT IT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED, HOWEVER, THE TIP PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13185253 ↗
• InjuryJan 6, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED VIA MEDWATCH MW5105152 THAT TIP DETACHMENT OCCURRED. THE PHYSICIAN PLACED A SAMURAI WIRE AND A NON-BOSTON SCIENTIFIC (BSC) WIRE IN THE VESSEL. A STENT WAS ADVANCED ON THE NON-BSC WIRE AND DEPLOYED, TRAPPING THE SAMURAI WIRE AGAINST THE VESSEL WALL. WHEN AN ATTEMPT WAS MADE TO REMOVE THE SAMURAI WIRE, THE WIRE SEPARATED LEAVING THE DISTAL END OF THE WIRE IN THE VESSEL WHICH WAS ABLE TO BE RETRIEVED USING A SNARE. THE PATIENT WAS NOT HARMED BUT REQUIRED INTERVENTION AND LONGER PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13184519 ↗
• MalfunctionOct 28, 2021Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 190CM SAMURAI GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE NON-BOSTON SCIENTIFIC BALLOON INFLATED TO 26 ATM AND INFLATED IT ABOUT 6 TO 7 TIMES. DURING WITHDRAWAL, THE NON-BOSTON SCIENTIFIC BALLOON WAS NO LONGER POSSIBLE TO RETRIEVE AND IT BECAME STUCK ON THE SAMURAI GUIDEWIRE. THE GUIDEWIRE POSITION WAS LOST. THE DEVICES WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. THE PROCEDURE WAS COMPLETED WITH A THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12713000 ↗
• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS SELECTED FOR USE. THE PHYSICIAN PRE-SHAPED THE WIRE PRIOR TO ENTERING THE PATIENTS BODY; HOWEVER, WHEN ADVANCING THE WIRE DOWN TO THE LAD, HE NOTICED A BREAK IN THE RADIOPAQUE PORTION OF THE WIRE. IT APPEARED AS IF THE WIRE HAD POSSIBLY BEEN BROKEN WHEN SHAPING. THE DEVICE WAS COMPLETELY REMOVED AND ANOTHER 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS SHAPED AND ADVANCED INTO THE PATIENT'S BODY, BUT THE PHYSICIAN AGAIN NOTICED A BREAK IN THE RADIOPAQUE PORTION OF THE WIRE. THE PROCEDURE WAS COMPLETED AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615953 ↗
• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS SELECTED FOR USE. THE PHYSICIAN PRE-SHAPED THE WIRE PRIOR TO ENTERING THE PATIENTS BODY; HOWEVER, WHEN ADVANCING THE WIRE DOWN TO THE LAD, HE NOTICED A BREAK IN THE RADIOPAQUE PORTION OF THE WIRE. IT APPEARED AS IF THE WIRE HAD POSSIBLY BEEN BROKEN WHEN SHAPING. THE DEVICE WAS COMPLETELY REMOVED AND ANOTHER 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS SHAPED AND ADVANCED INTO THE PATIENT'S BODY, BUT THE PHYSICIAN AGAIN NOTICED A BREAK IN THE RADIOPAQUE PORTION OF THE WIRE. THE PROCEDURE WAS COMPLETED AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615948 ↗
• MalfunctionMar 9, 2021Entrapment of Device; Device-Device Incompatibility; Material Integrity Problem; Entrapment of Device; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDEWIRE BECAME STUCK INSIDE A GUIDE CATHETER. A 190CM SAMURAI GUIDEWIRE WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI). INSIDE THE PATIENT, WHILE INTRODUCING THE GUIDEWIRE THROUGH A NON-BOSTON SCIENTIFIC GUIDE CATHETER, THE TIP OF THE GUIDEWIRE WENT THROUGH A SIDE HOLE OF THE GUIDE CATHETER AND BECAME STUCK. THE GUIDEWIRE WAS WITHDRAWN, AND IT WAS NOTED THAT THE TIP HAD THINNED AND PULLED APART, BUT IT DID NOT FULLY SEPARATE. 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 11449243 ↗
• InjuryNov 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED AND THE PATIENT EXPERIENCED CHEST PAIN. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE FRACTURED. IT TOOK A VERY LONG TIME TO CROSS THE LESION, ONCE THE WIRE CROSSED THE LESION THE PATIENT STARTED HAVING CHEST PAIN SO THE PHYSICIAN OPTED TO CONTINUE WITH USING THE SAME GUIDEWIRE. THE WIRE WAS REMOVED INTACT AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: Chest Pain

  MAUDE report 10816643 ↗
• InjuryJul 6, 2020Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT GUIDEWIRE COATING PEELED OFF. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE COATING ON THE TIP WAS PEELED OFF. THE PEELED COATING WAS ONLY PARTIALLY REMOVED DUE TO CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10235826 ↗