Peripheral RotaWire™ and wireClip® Torquer M0011373320Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729863649), received between May 30, 2017 and Jun 18, 2026 — classified as 1 death, 11 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2026Contamination; Positioning Problem

  IT WAS REPORTED THAT GUIDEWIRE POSITION LOSS OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED BELOW THE KNEE ARTERY. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. WHEN THE ROTA BURR WAS REMOVED FROM THE BODY THE WIRE CAME OUT AS WELL. THE WIRE TOUCHED A NON-STERILE ITEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550633 ↗
• InjuryOct 16, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BURR WAS DISLODGED AND STUCK IN THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR TIBIAL ARTERY ATHERECTOMY. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE AND THE DEVICE WERE LODGED IN A CHRONIC OCCLUSION IN THE PERONEAL ARTERY. THE DEVICES COULD NOT BE WITHDRAWN THROUGH THE COMMON FEMORAL ARTERIOTOMY. INTERVENTION INCLUDED EXPOSING THE PERONEAL ARTERY THROUGH THE LOWER LEG TO CUT THE DEVICE FREE AT THE DISTAL END OF THE DEVICE. THE REST OF THE ROTABLATOR WAS REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE LESION WAS 4-5MM LONG. THE PATIENT WAS MEDICATED WITH VERAPIMIL AND NITRO IN THE ROTAGLIDE SOLUTION. THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310510 ↗
• MalfunctionOct 7, 2025Difficult 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 REMOVAL DIFFICULTY OCCURRED. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAWIRE WAS DELIVERED THROUGH THE RUBICON CATHETER. THERE WAS A RESISTANCE EXCHANGING THE WIRE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23234500 ↗
• MalfunctionOct 3, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A BURR AND WIRE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED PROXIMAL TO DISTAL ANTERIOR TIBIAL ARTERY (ATA). A 1.25 MM ROTAPRO-PI AND PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE IN ACCORDANCE WITH STANDARD ATHERECTOMY INDICATIONS. BURR ADVANCEMENT WAS PERFORMED USING A PECKING MOTION APPROXIMATELY 75% OF THE TIME. THE BURR WAS USED CLOSE TO THE ORIGIN OF THE ATA AND TRAVELED DISTALLY TOWARD THE PEDAL ARTERIES. MIDWAY THROUGH THE ATA, THE BURR BEGAN TO STALL, INCLUDING DURING DYNAGLIDE MODE. ADVANCEMENT BECAME DIFFICULT AT THE MIDPOINT OF THE LESION. IT WAS OBSERVED THAT THE GUIDEWIRE WAS NOT FREELY MOVING WITHIN THE VESSEL AND WAS MOVING TOGETHER WITH THE BURR, INDICATING THE BURR HAD BECOME STUCK ON THE WIRE. MULTIPLE ATTEMPTS WERE MADE TO DISLODGE THE BURR USING BOTH NORMAL AND DYNAGLIDE MODES, BUT THESE WERE UNSUCCESSFUL. THE PHYSICIAN ELECTED TO REMOVE THE ROTAPRO BURR; HOWEVER, IT COULD NOT BE EXTRACTED INDEPENDENTLY OF THE WIRE. CONSEQUENTLY, BOTH THE BURR AND GUIDEWIRE WERE REMOVED TOGETHER AS A SINGLE UNIT. POST-REMOVAL, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214042 ↗
• InjuryJun 6, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE BROKE OFF AND WAS UNRETRIEVED. THE PATIENT WAS NOT DISCHARGED FROM THE HOSPITAL. THE 89% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SEGMENT FROM THE POPLITEAL ARTERY TO THE PROXIMAL ANTERIOR TIBIAL ARTERY. A PER ROTA WIRE EXSUP WAS SELECTED FOR LEFT LEG ATHERECTOMY. DURING THE PROCEDURE, THE WIRE WAS CHECKED IF IT IS STILL IN PLACE AND A SMALL PIECE OF THE END OF THE WIRE WAS NOTICED TO BE SEPARATED FROM THE WIRE ITSELF. A SPIDER FILTER WAS PLACED BEYOND THE PIECE OF THE WIRE IN THE HOPES OF CAPTURING IT AFTER A FEW TRIES WITHOUT SUCCESS AND A SMALL SEGMENT OF THE TIP AT 5MM IN LENGTH REMAINS AND WILL REMAIN IN THE PATIENT'S DISTAL AT/PEDAL ARTERY. AN OVER THE WIRE (OTW) STERLING BALLOON WAS INFLATED IN THE AT ARTERY (ABOVE THE WIRE PIECE) AS WOULD NORMALLY BE DONE AFTER ATHERECTOMY. NO FLOW WAS OBSERVED FOR A SHORT SEGMENT FROM DISTAL POPLITEAL TO PROXIMAL AT ARTERY. ADDITIONALLY, IT WAS NOTICED THAT THE DISTAL POPLITEAL AS WELL AS THE PROXIMAL AT ARTERY WAS THROMBOSED. PATIENT WAS TRANSFERRED TO THE HOSPITAL TO HAVE A CATHETER PLACED FOR THROMBOLYSIS ACROSS AREA THAT WAS THROMBOSED. THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22159740 ↗
• InjuryMar 6, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE WIRE DETACHED, AND ADDITIONAL SURGERY WAS REQUIRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. A ROTAWIRE WAS SELECTED FOR ATHERECTOMY. DURING PROCEDURE, FOLLOWING ROTABLATION, A STERLING BALLOON WOULD NOT ADVANCE OVER THE WIRE AND THE WIRE APPEARED KINKED. THE WIRE THEN BROKE INTO TWO PIECES, MID WIRE. FURTHERMORE, THE PATIENT UNDERWENT ENDARTERECTOMY AND THE DISTAL END OF THE ROTAWIRE WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848565 ↗
• MalfunctionJan 23, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A DEVICE ENTRAPMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED POSTERIOR TIBIAL ARTERY. A 1.75MM ROTAPRO AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHEN ADVANCING THE BURR THROUGH THE LESION, THE BURR WAS NOT SPINNING, AND THE WIRE WAS FLOPPING ON THE BACK TABLE INDICATING THAT THE BURR WAS STUCK ON THE WIRE. THE BURR AND WIRE WERE REMOVED TOGETHER AS ONE UNIT. THERE SEEMED TO BE AN INTIMAL TISSUE WRAPPED AROUND THE CATHETER TIP WHEN REMOVED, THAT WAS SUSPECTED TO BE THE CAUSE OF THE DEVICE BECAME STALL AND STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566175 ↗
• MalfunctionJul 6, 2023Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR ATHERECTOMY PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THERE WAS A WHITE SMUDGE ON THE DISTAL END OF THE ROTAWIRE. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270738 ↗
• InjuryMar 8, 2023Fracture; Detachment of Device or Device Component; Material Deformation; Fracture; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE GUIDEWIRE WAS FRACTURED AND AN ADDITIONAL SURGERY WAS REQUIRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY (PT). A PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER - BX5 WAS SELECTED FOR USE AND INSERTED THROUGH A BERN CATHETER. DURING THE PROCEDURE, THE 5FR BERN CATHETER WAS REMOVED AND LEFT-SIDED 5/6 FR SLENDER SHEATH ACCESS WAS LOST. UPON REINSERTION OF THE PEDAL SHEATH OVER THE WIRE, THE ROTAWIRE LOOPED, KINKED AND BROKE OFF IN THE FOOT. NO HEMATOMA OR ACTIVE BLEEDING WAS NOTED. THE PHYSICIAN ATTEMPTED TO RE-STICK THE LEFT PT WITH THE ULTRASOUND GUIDANCE, BUT NO VESSEL WAS VISUALIZED AND SPASM WAS PRESUMED. RIGHT COMMON FEMORAL ARTERY ACCESS WAS OBTAINED WITH A 6FR SHEATH. HOWEVER, THE PHYSICIAN NOTICED THAT THE ROTAWIRE WAS NOW LOCATED IN THE DESCENDING SUPERIOR VENA CAVA. A 6FR SNARE WAS USED IN AN ATTEMPT TO REMOVE THE DEVICE. THE ROTAWIRE WAS PULLED INTO THE RIGHT COMMON ILIAC ARTERY, BUT BROKE IN THE SNARE. THE INTENDED PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS THEN TRANSPORTED TO A VASCULAR SURGEON FOR REMOVAL OF THE WIRE. A SMALL INCISION WAS MADE IN THE TOP OF THE LEFT FOOT AND

  Patient problems: Vasoconstriction

  MAUDE report 16503731 ↗
• InjuryJul 28, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WAS BLOOD-TINGED TISSUE PRESENT ON THE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, A 2.00MM PERIPHERAL ROTALINK PLUS SYSTEM BEGAN MAKING A HIGH-PITCHED NOISE AND THE BURR SEEMED TO BE STUCK AS THE PHYSICIAN ATTEMPTED TO MOVE IT SLIGHTLY BACK AND FORTH WITHOUT SUCCESS. THE PHYSICIAN THEN SWITCHED TO DYNAGLIDE MODE TO COMPLETELY REMOVE THE BURR OUT OF THE PATIENT'S BODY AND WAS ABLE TO DO SO. WHEN THE ROTAWIRE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THERE WAS BLOOD-TINGED TISSUE PRESENT ON THE WIRE. 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 15121456 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE ROTAWIRE WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A ROTAWIRE AND WIRECLIP TORQUER (BX5) AND A 1.50MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE FOOT PEDAL WAS STEPPED ON AND BEGAN TO ADVANCE THE BURR, IT WAS MAKING AN ABNORMAL SOUND. THE DEVICE WAS STOP AND PULLED BACK THE ROTAWIRE A BIT BUT THE END OF THE WIRE WAS NOT COMING BACK. THE PHYSICIAN ASSUMED THE WIRE WAS BROKEN APPROXIMATELY 20-30 CM FROM DISTAL END. THEY REMOVED THE PROXIMAL PORTION OF THE ROTAWIRE WHILE THE DISTAL PORTION REMAIN VISIBLE BEYOND THE ROTA DEVICE IN THE TIBIAL. WHEN THE ROTALINK PLUS WAS REMOVED, THE DISTAL WIRE CAME WITH IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066527 ↗
• MalfunctionFeb 15, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH THE ROTAWIRE. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED PERINEAL ARTERY. A 2.5MMX150MMX150CM COYOTE AND A 330CM ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT NOMINAL PRESSURE AND IT WAS NOTED THAT THE BALLOON BECAME STUCK WITH THE ROTAWIRE. BOTH BALLOON AND ROTAWIRE WERE REMOVED TOGETHER AS ONE UNIT WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534780 ↗
• MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE BECAME SEPARATED. THE 50-70% TARGET LESION WAS LOCATED IN THE MILDLY - NON TORUTOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE .014 PORTION OF THE WIRE BECAME SEPARATED FROM .009 PORTION. THE WIRE AND TIP WERE REMOVED INTACT THROUGH RUBICON CATHETER AND NO PORTION OF THE WIRE EMBOLIZED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745438 ↗
• InjuryAug 24, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT THE ROTAWIRE BROKE AND WAS SNARED TO REMOVE. VASCULAR ACCESS WAS OBTAINED VIA ANTERIOR TIBIAL (AT) ARTERY. A PERIPHERAL ROTAWIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAWIRE WAS USED FOR SUCCESSFUL ATHERECTOMY OF THE AT ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA), AND WAS THEN USED AS A RAIL TO BALLOON THE AT ARTERY. WHEN REMOVING THE BALLOON, THE NON-BSC SHEATH CAME OUT OF THE ACCESS POINT OUT OF THE BODY. WHEN TRYING TO REINSERT THE SHEATH OVER THE ROTAWIRE, THE SHEATH WAS UNABLE TO ADVANCE. THE ROTAWIRE WAS MANIPULATED SEVERAL TIMES. IT WAS PULLED BACK, LOOPED, AND KINKED ON ITSELF. THE ROTAWIRE BROKE IN HALF INSIDE THE PATIENT BODY. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT COMMON FEMORAL ARTERY (CFA). A SNARE WAS SUCCESSFULLY USED TO REMOVE THE REMAINING ROTAWIRE INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359616 ↗
• DeathApr 26, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTABURR BECAME STUCK WITHIN THE LESION, THE ROTABURR AND ROTAWIRE WERE DIFFICULT TO REMOVE, THE PROCEDURE WAS ABORTED, THE PATIENT WENT TO SURGERY THEN LATER DIED DURING SURGERY. A 2.00MM PERIPHERAL ROTALINK PLUS ATHERECTOMY CATHETER BURR AND A PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE IN A TIBIAL ATHERECTOMY PROCEDURE. THE PATIENT WAS BEING TREATED AT AN OUTPATIENT FACILITY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERONEAL ARTERY. THE DEVICES WERE ADVANCED TO THE LESION AND ATHERECTOMY WAS PERFORMED WITH A SET ROTATIONAL SPEED OF 180,000RPM. THE BURR STALLED AND BECAME LODGED INTO THE PERONEAL ARTERY. THE BURR COULD NOT BE REMOVED FROM THE PERONEAL ARTERY. AT THE TIME THE BURR BECAME STUCK IN THE PERONEAL ARTERY THE PATIENT EXPERIENCED A VASOSPASM WHICH MAY HAVE PLAYED A ROLE IN THE BURR BECOMING STUCK WITHIN THE PERONEAL ARTERY. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS TRANSFERRED VIA AN AMBULANCE TO THE HOSPITAL TO HAVE THE DEVICES REMOVED SURGICALLY. THE PERIPHERAL ROTAWIRE GUIDEWIRE WAS REMOVED BUT THE PATIENT EXPERIENCED A CARDIAC EVENT INCLUDING MYOCARDIAL INFARCTION. DURING THE BURR

  Patient problems: Myocardial Infarction; Vasoconstriction

  MAUDE report 11726882 ↗
• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BURR DETACHMENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS, A PERIPHERAL ROTAWIRE GUIDEWIRE AND A 2.5MM X 20MM X 143CM COYOTE ES BALLOON WERE SELECTED FOR USE. DURING THE PRIMING/PLATFORMING OF THE ROTALINK, THE PHYSICIAN NOTICED THAT THE BURR DISLODGED FROM THE CATHETER. THE BURR WAS SITTING ON THE WIRE DETACHED FROM THE TIP OF THE CATHETER. THEY IMMEDIATELY DISCARDED/PUT ASIDE THE WHOLE SETUP INCLUDING ROTAWIRE NUMBER ONE. THEY OPENED UP A SECOND ROTALINK AND A SECOND ROTAWIRE TO CONTINUE WITH THE PROCEDURE. THE ROTALINK NUMBER TWO WORKED FINE AND WAS REMOVED WITHOUT ANY ISSUES. THEY THEN OPENED A COYOTE BALLOON TO POST DILATE THE LESION BUT THE BALLOON WOULD NOT ADVANCE PROPERLY. PHYSICIAN DECIDED TO REMOVE THE BALLOON AND EXCHANGE THE WIRE, THE BALLOON WAS REMOVED AND INTACT. THE PHYSICIAN USED A RUBICON/SAVION COMBINATION TO BUDDY WIRE. ONCE THE SAVION GUIDEWIRE WAS IN PLACE, THE PHYSICIAN REMOVED THE ROTAWIRE. HOWEVER, ROTAWIRE NUMBER TWO UPON REMOVAL, BROKE OFF BY THE DISTAL TIP. THE BREAK OCCURRED WHEN THE WIRE WAS COMING OUT OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617196 ↗
• MalfunctionDec 10, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTABURR BECAME STUCK IN THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL VESSEL. A 1.75MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT BOTH DEVICE BECAME STUCK TOGETHER INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. NO NEGATIVE SEQUELAE OCCURRED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10985493 ↗
• MalfunctionNov 20, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS UNABLE TO RETRACT OVER THE WIRE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 2.00MM PERIPHERAL ROTALINK PLUS AND A PERIPHERAL ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, THE BURR STALLED ON TWO OCCASIONS. SUBSEQUENTLY, UPON WITHDRAWAL, IT WAS NOTED THAT THE BURR COULD NOT BE RETRACTED OVER THE ROTAWIRE. THE DEVICES WERE ABLE TO BE REMOVED AS A SINGLE UNIT FROM THE PATIENT'S BODY, BUT LOST WIRE ACCESS WIRE ACROSS THE LESION. A NEW ACCESS WAS OBTAINED AND SUCCESSFUL ANGIOPLASTY WAS PERFORMED TO COMPLETE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875421 ↗
• MalfunctionAug 28, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT AND BALLOON RUPTURE WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER AND A BX5 PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR THE PROCEDURE. DURING THE PROCEDURE, THE BALLOON COULD NOT BE PULLED BACK OVER THE WIRE AND BOTH WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. THE WIRE WAS STUCK IN THE BALLOON. A NEW BALLOON AND WIRE WERE OPENED TO COMPLETE THE PROCEDURE. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467455 ↗
• MalfunctionJan 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE WIRE BROKE OFF. THE TARGET LESION AREA WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A PERIPHERAL ROTAWIRE WAS SELECTED FOR USE ALONG WITH A 1.50MM PERIPHERAL ROTALINK PLUS. DURING THE PROCEDURE, THE LESION WAS SO SEVERE THAT THE DEVICE FAILED TO ADVANCE. SUBSEQUENTLY, AFTER TWO ROTATIONAL RUNS OF ROTABLATOR, IT WAS NOTED THAT THE WIRE SNAPPED OFF AT THE END OF THE CATHETER AND PART OF IT LEFT REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS SENT FOR A PROCEDURE TO RETRIEVE DEVICE FRAGMENTS AND IT WAS SUCCESSFUL. THE PATIENT WAS STABLE AFTER THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE ROTAWIRE BROKE OFF DURING PREPARATION AND IT WAS NOT INSERTED INTO THE PATIENT. THE PATIENT WAS SENT TO THE HOSPITAL IN A NON-EMERGENT/OUT-PATIENT SETTING.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9632262 ↗
• InjurySep 25, 2019Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT THE ROTAWIRE WAS SEPARATED AND REMAINED INSIDE PATIENT. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PULMONARY ARTERY (PA). FIRST, ABLATION WAS PERFORMED USING 1.5MM BURR IN THE PROXIMAL PA. TREATMENT WAS THEN CONTINUED IN THE DISTAL PA TO PROXIMAL PART USING 3.0X210MM NON BSC BALLOON CATHETER. THE LESION WAS NOT FULLY DILATED SO A 2.5X20MM NON BSC BALLOON CATHETER WAS USED. THE 1.5MM BURR WAS THEN EXCHANGED TO A 1.25MM BURR. IT WAS NOTED THE ROTAWIRE BECAME TRAPPED IN THE CALCIFICATION OF THE ARTERY AND THE ROTAWIRE BECAME TWISTED WHEN THE BURR WAS ROTATING. ROTAWIRE SEPARATION OCCURRED. THERE WERE TWO SEPARATED PARTS FOUND IN DISTAL PA. PART OF THE SEPARATED WIRE WAS SUCCESSFULLY IN THE PROXIMAL PART USING A SNARE. THE OTHER DETACHED PIECE WAS UNABLE TO BE RETRIEVE, SO IT REMAINED AS IT WAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS PULLED OUT FROM THE PATIENT'S BODY AND THERE WERE NO VISIBLE ISSUE/DAMAGED NOTED ON THE BURR. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9119322 ↗
• InjurySep 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING TIP BROKE. THE TARGET LESION WAS LOCATED IN A SMALL COLLATERAL BRANCH. A PERIPHERAL ROTAWIRE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE SPRING TIP WAS BROKEN. THE DISTAL TIP OF THE WIRE WAS LEFT INSIDE THE PATIENT'S BODY AND WAS NOT SNARED AS IT WAS LOCATED IN A SMALL BRANCH. IT WAS NOT ATTEMPTED TO BE RETRIEVED AND NO INTERVENTION WAS DONE. NO COMPLICATIONS MANIFESTED TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9010602 ↗
• MalfunctionJul 17, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE TIBIOPERONEAL TRUNK. A 2.00MM PERIPHERAL ROTALINK AND PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE STALLED DURING ADVANCEMENT. ABOUT 75% OF THE ROTABLATION WAS COMPLETED AND THE DEVICE WAS BEING WITHDRAWN IN DYNAGLIDE MODE WHEN THE BURR BECAME STUCK ON THE WIRE. THE PHYSICIAN HAD DIFFICULTY REMOVING IT FROM THE PATIENT'S BODY. THE ROTALINK AND ROTAWIRE WERE REMOVED TOGETHER. THE ROTABLATION PROCEDURE WAS COMPLETED WITH THIS DEVICE AS THE MAJORITY OF THE CASE WAS COMPLETED. THERE WERE MULTIPLE AREAS AND THE LAST AREA WAS WHERE THEY HAD THE PROBLEM. A NEW WIRE WAS ADVANCED AND BALLOONING COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799133 ↗
• InjuryJun 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDE WIRE FRACTURED. THE TARGET LESION WAS LOCATED IN THE LEFT LOWER EXTREMITY. PERIPHERAL ROTAWIRE WAS SELECTED FOR USE. AFTER A SUCCESSFUL ATHERECTOMY PROCEDURE, IT WAS NOTED THAT THE WIRE BROKE WHEN THE NON- BSC BALLOON WAS REMOVED FROM THE PATIENT'S BODY. THE BROKEN WIRE WAS THEN REMOVED USING A SNARE AND THE PROCEDURE WAS COMPLETED. IT WAS CONFIRMED THAT THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY. NO FURHTER COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696032 ↗
• MalfunctionJun 3, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN POSTERIOR TIBIAL VESSEL. A 2.00MM PERIPHERAL ROTALINK PLUS AND PERPIHERAL ROTAWIRE WERE SELECTED FOR AN ATHERECTOMY PROCEDURE. THE DEVICE WAS USED IN THE UPPER PORTION OF THE POSTERIOR TIBIAL VESSEL. THEN, THE DEVICE WAS ADVANCED TO THE MID POSTERIOR TIBIAL VESSEL AND BECAME ENTRAPPED ON THE WIRE WHILE WHEN ROTATION WAS OCCURRING. SINCE THE DEVICE WAS UNABLE TO BE ADVANCED OR REMOVED FROM THE WIRE, THE ROTALINK AND ROTAWIRE WERE REMOVED TOGETHER AS A UNIT. NO FURTHER ATHERECTOMY WAS COMPLETED AND THE PROCEDURE WAS COMPLETED WITH BALLOONING. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663541 ↗