RotaWire™ and wireClip™ Torquer H802232390010Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 08714729144168), received between Dec 17, 2016 and Aug 6, 2026 — classified as 2 deaths, 30 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (54 reports).

4 other recalls cover devices cleared under the same FDA submission (P900056); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159484 ↗
• InjuryNov 12, 2025Fracture; Nonstandard Device; Fracture; Nonstandard Device

  IT WAS REPORTED THAT THE BURR AND GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR DESCENDING ARTERY, A 1.50MM ROTABLATOR PLUS AND ROTAWIRE - IC WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATIONAL ATHERECTOMY GUIDEWIRE WAS FRACTURED, RESULTING IN THE SCRAPPING OF THE DEVICE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY, AND THE BURR CAUSED THE GUIDEWIRE TO FRACTURE. THE GUIDEWIRE FRAGMENT WAS NOT REMOVED FROM THE BODY.

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

  MAUDE report 23534822 ↗
• MalfunctionAug 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A ROTAWIRE WAS SELECTED FOR USE. PRIOR TO PROCEDURE, IT WAS REPORTED THAT WIRE HAS PRECIPITATION OUT OF BOX. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903575 ↗
• MalfunctionJul 28, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04JUL2025. IT WAS REPORTED THAT THE WIRE WAS KINKED. THE 97% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE WAS KINKED. THE DEVICE WAS REMOVED WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PORTION OF THE DISTAL END WAS DETACHED AND DID NOT RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22635523 ↗
• MalfunctionApr 2, 2025Material Deformation; Material Deformation

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 12MAR2025. IT WAS REPORTED THAT THE DEVICE WAS KINKED. THE 95% STENOSED TARGET LESION WITH 45MM LENGTH AND 3.5MM DIAMETER, WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTAWIRE EX SUPPORT GW (5) WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE ROTAWIRE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS GOOD POST PROCEDURE. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE SPRING TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751675 ↗
• MalfunctionDec 31, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE WIRE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM ROTABLATOR ROTALINK PLUS AND ROTAWIRE EX SUPPORT GW WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR GOT STUCK WITH THE WIRE AND WAS UNABLE TO BE REMOVED. THE BURR AND THE WIRE HAD TO BE REMOVED MANUALLY AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048135 ↗
• MalfunctionOct 31, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTALINK BURR AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT ROTAWIRE WAS STUCK AT THE TAIL END OF THE BURR CATHETER AND THE SPRING AT THE BACK OF THE ROTARY GRINDING HEAD HAD CREASES. THE BURR AND WIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578950 ↗
• MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A WIRE FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE FRACTURED INTO TWO PIECES. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081267 ↗
• DeathJul 3, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT WIRE DETACHED AND THE PATIENT DIED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR DESCENDING ARTERY. A 1.50 MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, A DEFORMITY/KINK WAS NOTED IN THE ROTAWIRE NEAR THE BRAKE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE BURR WHILE IN DYNAGLIDE MODE, THE WIRE BROKE AND THE FRAGMENT EMBOLIZED IN THE SEPTAL VESSEL. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND NO FLOW WAS IDENTIFIED IN THE ANTERIOR DESCENDING CORONARY ARTERY. ATTEMPTING TO OPEN THE VESSEL RESULTED IN SEVERAL CARDIAC ARRESTS. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY OPEN THE SEPTAL VESSEL, RESTORING CORONARY FLOW AND TRAPPING THE WIRE FRAGMENT BY DEPLOYING TWO SYNERGY STENTS, HOWEVER, THE PATIENT WAS IN SERIOUS CONDITION. CARDIAC RESUSCITATION WAS ATTEMPTED SEVERAL TIMES AND AN INTRA-AORTIC BALLOON WAS USED TO MAINTAIN CARDIOVASCULAR STABILITY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE USE (ICU) AND DIED THE FOLLOWING DAY.

  Patient problems: Cardiac Arrest; Foreign Body Embolism; Foreign Body In Patient; Insufficient Information; Reduced Blood Flow

  MAUDE report 19667665 ↗
• MalfunctionFeb 14, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE BURR WAS STUCK ON THE GUIDEWIRE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE EXTRA SUPPORT WERE SELECTED FOR USE. FOLLOWING THE PROCEDURE, DURING REMOVAL, IT WAS NOTED THAT THE ROTAWIRE WAS KINKED WITHIN THE ROTAPRO ADVANCER AND THE BURR WERE STUCK ON THE WIRE, CLOSE TO THE LESION. THE ROTAPRO AND ROTAWIRE WERE REMOVED AND REPLACED. PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705922 ↗
• MalfunctionFeb 6, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE BURR WAS STUCK ON THE GUIDEWIRE. A 1.50MM ROTAPRO AND ROTAWIRE EXTRA SUPPORT GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAPRO BURR WAS BLOCKED BY THE GUIDEWIRE AND THE GUIDEWIRE BENT. THE BURR AND THE GUIDEWIRE WERE REMOVED AND REPLACED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651464 ↗
• MalfunctionJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROTAWIRE DETACHED. A ROTAWIRE WAS SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE BROKE INTO TWO PIECES. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619492 ↗
• MalfunctionDec 8, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A 1.25MM ROTABLATOR ROTALINK PLUS AND 330CM ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTABLATOR BURR GOT STUCK ON THE ROTAWIRE. THE PHYSICIAN MANAGED TO RELEASE THE FIRST WIRE FROM THE SYSTEM, BUT THE SAME ISSUE OCCURRED WITH A SECOND ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 1.25MM ROTABLATOR ROTALINK PLUS AND A NEW ROTAWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290059 ↗
• MalfunctionSep 18, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE OUTER LAYER OF THE WIRE IS PEELING OFF. A ROTAWIRE EX SUPPORT WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE OUTER LAYER OF THE ROTA WIRE IS PEELING OFF. THE PHYSICIAN USED A NEW ONE TO REPLACE THIS DEVICE AND COMPLETED THE ATHERECTOMY. THE PATIENT IS NOT PRESENT ON THE TIME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764988 ↗
• MalfunctionAug 7, 2023Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT THE BURR WAS STUCK ON THE GUIDEWIRE. A ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE AND WAS WIPED WITH A WET COMPRESS UPON UNPACKING. THE ROTAWIRE GUIDEWIRE AND ROTAPRO DEVICE WERE USED TOGETHER DURING THE PROCEDURE. DURING RETRACTION OF THE DEVICES, THE ROTAPRO DRILL BECAME STUCK ON THE ROTAWIRE. THE ROTAWIRE WAS REMOVED MANUALLY AND IN DYNAGLIDE MODE. THE ROTAWIRE GUIDEWIRE WAS REMOVED INTACT AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME ROTAPRO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475973 ↗
• MalfunctionAug 7, 2023Entrapment of Device; Defective Device; Difficult to Advance; Entrapment of Device; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT THE BURR GOT STUCK ON WIRE. A ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE AND WAS DRESSED WITH A WET COMPRESS UPON UNPACKING. THE ROTAWIRE GUIDEWIRE AND ROTAPRO DEVICE WERE USED TOGETHER DURING THE PROCEDURE. DURING PULLBACK OF THE DEVICES, IT WAS DIFFICULT TO TRACK THE ROTAPRO BURR ON THE GUIDEWIRE AND THE WIRE APPEARED BLUNT. THE ROTAWIRE WAS REMOVED MANUALLY AND IN DYNAGLIDE MODE. THE ROTAWIRE GUIDEWIRE WAS REMOVED INTACT AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME ROTAPRO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17475400 ↗
• MalfunctionApr 10, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE GUIDEWIRE. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM, 1.25MM ROTALINK BURR AND TWO ROTAWIRES WERE SELECTED FOR USE. DURING THE PROCEDURE, THE FIRST ROTAWIRE WAS CROSSED AND THE PHYSICIAN PREPARED A 1.5X12MM NON-BOSTON SCIENTIFIC BALLOON FOR PRE-DILATION, BUT FAILED TO CROSS. A 7F NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS REPLACED AND THE GUIDEWIRE WAS EXCHANGE TO A GRINDING GUIDEWIRE THROUGH THE MICROCATHETER. AN IN VITRO TEST WAS PERFORMED AND AFTER THAT, THE PHYSICIAN DELIVERED THE BURR THROUGH THE Y-VALVE AND USED A LOW SPEED FOR EASIER DELIVERING, AT WHICH POINT IT FAILED TO PUSH AND INDICATED A STALL. AFTER STOPPING THE ROTATION SPEED AND RETRACTING, IT WAS FOUND THAT THE BURR WAS HOLDING WITH THE GUIDEWIRE AND COULD NOT BE WITHDRAWN FROM THE BURR ALONE. THEN, THE OPERATOR CHOSE TO WITHDRAW THE ABRASIVE HEAD TOGETHER WITH THE GUIDEWIRE BUT STILL COULD NOT WITHDRAWN. THE BURR WAS INSIDE THE GUIDING AT THE TIME OF THE INCIDENT AND THE PHYSICIAN THEN REPLACED THE GUIDE WIRE AND BURR, BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707179 ↗
• MalfunctionApr 6, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE GUIDEWIRE. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM, 1.25MM ROTALINK BURR AND TWO ROTAWIRES WERE SELECTED FOR USE. DURING THE PROCEDURE, THE FIRST ROTAWIRE WAS CROSSED AND THE PHYSICIAN PREPARED A 1.5X12MM NON-BOSTON SCIENTIFIC BALLOON FOR PRE-DILATION, BUT FAILED TO CROSS. A 7F NON-BOSTON SCIENTIFIC GUIDE CATHETER WAS REPLACED AND THE GUIDEWIRE WAS EXCHANGE TO A GRINDING GUIDEWIRE THROUGH THE MICROCATHETER. AN IN VITRO TEST WAS PERFORMED AND AFTER THAT, THE PHYSICIAN DELIVERED THE BURR THROUGH THE Y-VALVE AND USED A LOW SPEED FOR EASIER DELIVERING, AT WHICH POINT IT FAILED TO PUSH AND INDICATED A STALL. AFTER STOPPING THE ROTATION SPEED AND RETRACTING, IT WAS FOUND THAT THE BURR WAS HOLDING WITH THE GUIDEWIRE AND COULD NOT BE WITHDRAWN FROM THE BURR ALONE. THEN, THE OPERATOR CHOSE TO WITHDRAW THE ABRASIVE HEAD TOGETHER WITH THE GUIDEWIRE BUT STILL COULD NOT WITHDRAWN. THE BURR WAS INSIDE THE GUIDING AT THE TIME OF THE INCIDENT AND THE PHYSICIAN THEN REPLACED THE GUIDE WIRE AND BURR, BUT THE SAME PROBLEM OCCURRED. THE PROCEDURE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693641 ↗
• MalfunctionFeb 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE BURR AND ROTAWIRE RUPTURED. A 1.50MM ROTABLATOR ROTALINK PLUS AND ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT BOTH ROTABLATOR BURR AND ROTAWIRE RUPTURED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397816 ↗
• MalfunctionDec 8, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. PROCEDURE SUMMARY: THE 85% STENOSED TARGET LESION WAS IN THE MIDDLE TO PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 3MM IN LENGTH AND 3MM IN VESSEL DIAMETER. THE LESION ANATOMY WAS NOT TORTUOUS. THERE WAS A SIGNIFICANTLY GREATER THAN 45 AND LESS THAN 90 DEGREE BEND IN THE LESION WITH MODERATE CALCIFICATION. VASCULAR ACCESS WAS GAINED VIA A RIGHT FEMORAL ARTERY. A ROTAPRO 1.50MM AND A ROTAWIRE WERE SELECTED FOR TREATMENT. DURING PREPARATION THE ROTAWIRE BECAME STUCK WITHIN THE ROTAPRO ADVANCER HANDLE. BY ACTIVATING DYNAGLIDE MODE RESISTANCE WAS LOWERED AND ROTAWIRE WAS FULLY INSERTED. THE ROTAPRO 1.50MM AND A ROTAWIRE WERE POSITIONED CLOSE TO THE GUIDE CATHETER TIP IN THE PROXIMAL RCA. ABLATION WAS ATTEMPTED BUT FAILED TO REACH OPTIMUM SPEED. THE DEVICE STALLED. SWITCHED THE SYSTEM TO DYNAGLIDE MODE AND THEN BACK TO RESTART ABLATION. THE DEVICE STALLED. GUIDE CATHETER AND ROTAPRO 1.50MM POSITION WAS CHANGED SEVERAL TIMES TO GET OPTIMAL ALIGNMENT WITH THE VESSEL. THE DEVICE STALLED. THE ROTAPRO 1.50MM WAS RETRACTED IN DYNAGLIDE MODE AND EXPERIENCED STRONG RESISTANCE FROM ROTAWIRE. THE WHOLE SYSTEM WAS RETRACTED AND EXCHANGED FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939408 ↗
• InjuryJun 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DETACHMENT OF THE DEVICE OCCURRED RESULTING IN UNRETRIEVED DEVICE FRAGMENT. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.25MM ROTAPRO AND A ROTAWIRE WERE SELECTED FOR TREATMENT TO THE LESION. DURING ADVANCEMENT THERE WAS A LARGE BEND IN THE ANATOMY AND SIGNIFICANT RESISTANCE WAS ENCOUNTERED AT THE LESION. ROTATIONAL SPEED WAS SET TO 230,000 RMP. THE 1.25MM ROTAPRO BURR AND THE ROTAWIRE DETACHED WHILE IT WAS ABLATING THE LESION. NO SURGICAL TREATMENT WAS PERFORMED DUE TO THE PATIENT BLOOD FLOW WAS SECURED. THE DETACHED BURR WAS LEFT INSIDE THE BODY. BOTH DEVICE WERE ABLE TO BE RECOVERED. THE PROCEDURE HAS BEEN CANCELLED. PERCUTANEOUS CORONARY INTERVENTION OR BYPASS WILL BE CONSIDERED FOR FUTURE TREATMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT REMAINED STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14733889 ↗
• MalfunctionNov 8, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE ROTAWIRE. A 1.50MM ROTALINK AND A ROTAWIRE WERE SELECTED TO BE USED FOR AN ANGIOPLASTY PROCEDURE. THE ROTAPRO WAS PREPPED AND PLATFORMED AT 160000RPM OUTSIDE THE PATIENT,THEN ADVANCED OVER THE WIRE. DURING PROCEDURE, THERE WAS SIGNIFICANT RESISTANCE BETWEEN THE BURR AND ROTAWIRE DURING ADVANCEMENT SO THAT AT A POINT THE PHYSICIAN WAS UNABLE TO ADVANCE THE BURR ON THE WIRE TOWARDS THE LESION. THEN, THE ROTAWIRE GOT STUCK IN THE ROTALINK BURR. THE ROTAPRO AND THE ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT FROM THE PATIENT. THE PROCEDURE COMPLETED SUCCESSFULLY WITH ANOTHER 1.50 MM BURR AND ROTAWIRE DEVICES. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12774958 ↗
• MalfunctionNov 4, 2021Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BURR GOT STUCK ON THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTABLATOR AND A ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. SET ROTATIONAL SPEED WAS 180,000RPM WITH THE MAXIMUM SPEED AT 180,000 RPM. DURING REMOVAL, IT WAS NOTED THAT THE ROTABURR GOT STUCK ON THE ROTAWIRE. BOTH ROTABLATOR AND A ROTAWIRE WERE REMOVED TOGETHER FROM THE PATIENT BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS AND EVALUATION WAS COMPLETED ON 15DEC2021. VISUAL INSPECTION REVEALED THAT THE RETURNED GUIDEWIRE HAD THE SPRING TIP BENT/KINK. ALSO, THE DEVICE IS KINKED AT 12" FROM THE DISTAL END. MICROSCOPIC INSPECTION REVEALED THAT THE RETURNED GUIDEWIRE HAD THE SPRING TIP BENT/KINK. DIMENSIONAL INSPECTION REVEALED THAT THE COMPONENTS WERE WITHIN SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751836 ↗
• MalfunctionOct 27, 2021Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT THE ROTAWIRE HAS A WHITE FOREIGN SUBSTANCE ON SEVERAL LOCATIONS. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED ARTERY. TWO ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THERE WAS LARGE AND HARD LUMPS OF WHITE FOREIGN SUBSTANCE ON SEVERAL LOCATIONS AND COULD NOT BE REMOVED. A KINK WAS SEEMED TO BE PRESENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705336 ↗
• MalfunctionOct 27, 2021Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED THAT THE ROTAWIRE HAS A WHITE FOREIGN SUBSTANCE ON SEVERAL LOCATIONS. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED ARTERY. TWO ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THERE WAS LARGE AND HARD LUMPS OF WHITE FOREIGN SUBSTANCE ON SEVERAL LOCATIONS AND COULD NOT BE REMOVED. A KINK WAS SEEMED TO BE PRESENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704032 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P900056. One submission often covers many models, so check the product and lot details in each record.

• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• Z-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• Z-0212-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rota
• Z-0211-2016 · Oct 9, 2015 · Terminated
  RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator