ROTAPRO™ H749393001750Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08714729893370), received between May 24, 2019 and Mar 11, 2025 — classified as 3 deaths, 10 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• DeathMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA), OSTIUM SUBTOTAL, THE LESION WAS MODERATELY TORTUOUS, SEVERELY CALCIFIED AND 90% STENOSED. A 6F GUIDING CATHETER WAS SELECTED FOR TREATMENT , AND THEN REPLACED WITH A 7F CATHETER. INITIALLY A NON-BOSTON SCIENTIFIC WIRE WAS USED, THEN CHANGED TO A ROTAWIRE FLOPPY VIA A MICROCATHETER, ALONG WITH A 1.75 MM ROTAPRO. FOUR RUNS OF ROTATIONAL ATHERECTOMY WERE CONDUCTED, EACH ABOUT 20 SECONDS, WITH A MAXIMUM RPM DROP OF 15 K. HOWEVER, NO REFLOW OCCURRED, LEADING TO BALLOON ANGIOPLASTY AND IMPLANTATION OF TWO STENTS. THERE WAS NO ANTEGRADE FLOW OBSERVED IN THE CORONARY ARTERY (NO TIMI FLOW), CAUSING AV BLOCK, AND REQUIRING A TEMPORARY PACEMAKER. COMPLICATIONS THAT WERE ENCOUNTERED INCLUDED MYOCARDIAL INFARCTION/ISCHEMIA AND FURTHER INTERVENTIONS INCLUDED ADMINISTRATION OF ISOPREL, AGOSTAT, KATECHOMALIN, ATROPIN, AND USE OF A TEMPORARY PACEMAKER. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT (CCU). THOUGH NO DEVICE MALFUNCTIONS OCCURRED, THE PHYSICIAN IS UNSURE IF THE DEVICE OR PROCEDURE CONTRIBUTED TO THE COMPLICATIONS. HOWEVER, FURTHER INFORMATION CONFIRMED DEA

  Patient problems: Ischemia; Myocardial Infarction; Reduced Blood Flow

  MAUDE report 21572780 ↗
• MalfunctionAug 22, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON GUIDEWIRE. A 1.75MM ROTAPRO AND ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAPRO BURR SEIZED FIRMLY ON THE WIRE AND COULD NO LONGER BE SEPARATED, AND THE BURR COULD NO LONGER GO FORWARD OR BACKWARDS. ROTAWIRE AND BURR WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER ROTAPRO AND ROTAWIRE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039068 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTAPRO BURR BROKE OFF THE DRIVE SHAFT. THE BURR WAS RETRIEVED UTILIZING THE REMOVAL OF THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760908 ↗
• MalfunctionMay 2, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. A 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.75MM ROTAPRO WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE ROTATION SPEED WAS SET TO 190,000 RPM. HOWEVER, WHEN THE POSITION OF THE BURR WAS RETURNED TO THE PLATFORM INSIDE THE BODY AT THE END OF THE ABLATION, IT WAS NOTED THAT THE ROTATION SPEED INCREASED TO A MAXIMUM OF 310,000 RPM. AFTER REMOVING THE BURR FROM THE PATIENT WITHOUT USING DYNAGLIDE MODE, THE ROTAWIRE WAS ALSO REMOVED FROM THE BODY TO CHECK FOR ANY ABNORMALITIES IN APPEARANCE. BOTH BURR AND WIRE DID NOT SHOW ANY APPEARANCE ABNORMALITIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 2.0 MM ROTAPRO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856131 ↗
• MalfunctionMar 23, 2023Output Problem; Material Split, Cut or Torn; Output Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A RUPTURE OF THE SHEATH OCCURRED. A 1.75MM ROTAPRO WAS SELECTED FOR USE. IT WAS NOTED THAT THERE WAS A RUPTURE OF THE SHEATH DURING USE. A DROP IN ROTATIONAL SPEED OCCURRED. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599338 ↗
• InjuryMar 13, 2023Device Contamination with Body Fluid; Output Problem; Material Split, Cut or Torn; Device Contamination with Body Fluid; Output Problem; Material Split, Cut or Torn

  IT WAS NOTED THAT THE DEVICE WAS LEAKING BLOOD. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, 22MM IN LENGTH, CONCENTRIC, DE NOVO (PROGRESSION) TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON ADVANCING IN THE LEFT MAIN AND PROXIMAL LAD, STARTING WITH A HIGH-SPEED ROTATION WITH A PROCEDURAL TARGET OF 160,000RPM, THE MAXIMUM ROTATION SPEED REACHED AT 162,000RPM. IT WAS THEN NOTED THAT BLOOD AND AIR WAS COMING OUT IN THE ADVANCER, JUST BENEATH THE ADVANCER KNOB. THERE WAS DECLINE IN VITAL SIGNS AS A RESULT OF BLOOD LOSS BUT WAS QUICKLY INJECTED WITH ATROPINE. THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENT, AND IT WAS NOTED THERE WAS A TEAR IN THE ROTA SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16535118 ↗
• MalfunctionOct 17, 2022Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A ROTAPRO 1.75MM ATHERECTOMY CATHETER WAS SELECTED FOR CORONARY TREATMENT. CATHETER SEPARATION WAS OBSERVED RESULTING IN THE ROTAWIRE LAYING FREELY WITHIN THE VESSEL. RETRIEVAL OF THE ROTAPRO 1.75MM ATHERECTOMY CATHETER WAS DIFFICULT. THE ROTAPRO 1.75MM ATHERECTOMY CATHETER WAS FULLY RETRIEVED AND WITHDRAWN FROM THE PATIENT. NO PATIENT COMPLICATIONS REPORTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTAPRO 1.75MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617221 ↗
• InjurySep 12, 2022Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE BURR ENTRAPMENT AND REQUIRED SURGERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). A 1.50MM ROTAPRO DEVICE WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. DURING PROCEDURE, THE ROTATION SPEED DROPPED FROM THE TARGET SPEED 160,000RPM. THEN, THE PHYSICIAN USED 1.75MM ROTAPRO DEVICE AND UPON THE FIRST PASS, THE BURR GOT STUCK IN LESION. THE DEVICE STALLED AND WOULD NOT PULL BACK. AN ATTEMPTED TO GIVE NITROGLYCERIN, THE PATIENT COUGHED, THE PHYSICIAN ADVANCED ANOTHER WIRE AND BALLOON NEXT TO BURR AND RETRACT WITH GUIDE EXTENSION WITHOUT ANY SUCCESS. THEN, THE PATIENT WENT TO THE OPERATING ROOM FOR A CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY OF THE RCA. THE PATIENT CAME THROUGH SURGERY WITHOUT ANY COMPLICATIONS AND WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Cough

  MAUDE report 15404390 ↗
• MalfunctionSep 2, 2022Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT BURR DETACHMENT OCCURRED. A BURR DETACHMENT OCCURRED TO A ROTAPRO 1.75MM ATHERECTOMY CORONARY CATHETER DURING TESTING PREPARATION PRIOR TO PATIENT INTRODUCTION. THE BURR DETACHED FROM THE ADVANCER. A NEW ROTAPRO WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349050 ↗
• InjuryAug 10, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BURR SEPARATION OCCURRED. A 50% TO 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED OSTIAL RIGHT CORONARY ARTERY (RCA). A 1.75MM ROTAPRO DEVICE WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. DURING ROTABLATION, THE BURR WAS SUDDENLY DETACHED FROM THE ADVANCER. THE PHYSICIAN USED A A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER TO PRESS THE BURR INTO THE WIRE AND THE GUIDE CATHETER. THE BURR WAS REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH TWO SYNERGY MEGATRON WITH OPTIMAL EXPANSION IN THE LESION. NO PATIENT HARM RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200442 ↗
• MalfunctionJun 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURED AND THE PROCEDURE WAS CANCELLED. A ROTAPRO 1.75MM WAS BEING USED FOR TREATMENT. DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN NOTED THAT THE ADVANCER KNOB WAS UNABLE TO BE MOVED. THEY ATTEMPTED TO SCREW AND UNSCREW THE KNOB MULTIPLE TIMES, BUT THE ADVANCER KNOB WAS STILL UNABLE TO BE MOVED. UPON INSPECTION THE PHYSICIAN ALSO NOTED THAT THERE WAS A WHITE CABLE THAT WAS BLOCKING THE PATH OF THE ADVANCER KNOB. THE DEVICE WAS REPLACED WITH ANOTHER ROTAPRO, HOWEVER THERE WERE DIFFICULTIES IN LOADING THE BURR ON TO THE ROTAWIRE. THE ROTAWIRE WAS THOUGHT TO BE BROKEN WITHIN THE ADVANCER OF THE SECOND ROTAPRO. DUE TO THE ISSUES WITH THESE THREE DEVICES, THE PROCEDURE WAS UNABLE TO BE COMPLETED AT THAT TIME. THE SEDATION STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14835511 ↗
• MalfunctionMar 4, 2022Break; Entrapment of Device; Intermittent Loss of Power; Break; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND THE SHAFT BROKE. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN (LM) VESSEL. A 1.75MM ROTAPRO WAS SELECTED FOR USE ATHERECTOMY PROCEDURE. DURING PROCEDURE, THE ROTA PRO STALLED AND THE ROTA PRO BURR BECAME STUCK IN THE STENOSIS. THE ROTAPRO CATHETER CONTINUED TO ROTATE DISTAL TO THE ROTPRO BURR. THE DRIVE SHAFT BECAME LOOSE AND DETACHED. A GUIDE CATHETER WAS ADVANCED FOR SUPPORT. THE GUIDE CATHETER WAS PUSHED INTO THE VESSEL TO REMOVE THE DETACHED PORTION OF THE DRIVE SHAFT AND ROTAPRO BURR. THE FRACTURED ROTAPRO DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-COMPLAINT BALLOONS AND STENTS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13675805 ↗
• MalfunctionFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power; Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED (B)(6) 2022. IT WAS REPORTED THAT A STALL OCCURRED. A ROTAPRO 1.75MM WAS SELECTED FOR USE TO TREAT AN 85% STENOSED MODERATELY CALCIFIED NON-TORTUOUS TARGET LESION WITHIN THE RIGHT CORONARY ARTERY. AFTER SUCCESSFUL ATHERECTOMY, THE DEVICE STALLED WHILE IN DYNAGLIDE MODE AS THE ROTAPRO 1.75MM WAS BEING WITHDRAWN FROM THE PATIENT. THE PHYSICIAN TURNED DYNAGLIDE OFF AND WAS ABLE TO REMOVE THE BURR SUCCESSFULLY AND INTACT. THE ROTAPRO 1.75MM WAS REMOVED SUCCESSFULLY INTACT WITHOUT THE USE OF DYNAGLIDE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. HOWEVER DEVICE ANALYSIS REVEALED A TORN SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543041 ↗
• MalfunctionJan 31, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BURR SEPARATION OCCURRED. A 1.75MM ROTAPRO WAS SELECTED FOR THE RIGHT CORONARY ARTERY (RCA) PROCEDURE. WHILE THE PHYSICIAN ADJUSTING THE ROTATION SPEED TO 180,000RPM, THE ROTAPRO BURR DETACHED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTAPRO DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13393367 ↗
• MalfunctionJan 24, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. A ROTAPRO 1.75MM AND ROTAWIRE DRIVE WERE SELECTED TO TREAT A 95% STENOSED TARGET AND SEVERELY CALCIFIED AND SEVERELY TORTUOUS LESION WITHIN THE CORONARY ARTERY. AFTER ABLATION THE DEVICES WERE ATTEMPTED TO BE REMOVED BUT WERE STUCK. A KINK WAS PRESENT ON THE ROTAWIRE DRIVE. BOTH DEVICES WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13334080 ↗
• MalfunctionDec 17, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHAFT BREAK AND SALINE LEAK OCCURRED. A ROTAPRO 1.75MM WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE IT WAS OBSERVED THAT SALINE WAS LEAKING 20CM DISTAL FROM THE DRIVE SHAFT SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026167 ↗
• MalfunctionOct 14, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A CALCIFIED LESION. A 1.75MM ROTAPRO WAS USED FOR TREATMENT, BUT DURING INSERTION INTO THE PATIENT THE BURR BECAME STUCK ON THE GUIDEWIRE. THE BURR AND THE GUIDEWIRE WERE REMOVED OUTSIDE THE PATIENT TOGETHER, AND THE PROCEDURE WAS THEN COMPETED WITH A DIFFERENT 1.75MM ROTAPRO DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632288 ↗
• MalfunctionAug 18, 2021Output Problem; Output Problem

  IT REPORTED THAT THERE WAS UNSTABLE SPEED. A 1.75MM ROTAPRO WAS SELECTED TO TREAT A 90% STENOSED SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. DURING PROCEDURE, THE ROTATIONAL SPEED WAS UNSTABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337905 ↗
• MalfunctionJul 22, 2021Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE ROTAPRO BECAME STUCK TO THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTAPRO 1.75MM AND ROTAWIRE WERE SELECTED FOR USE. THE DEVICES WERE ADVANCED TO THE LESION. ROTATIONAL SPEED WAS SET TO 180,000 RPM. ATHERECTOMY WAS PERFORMED. STALL OCCURRED WHEN REMOVING THE ROTAPRO IN DYNAGLIDE MODE. IT WAS NOTED THAT THE ROTAPRO BECAME STUCK TO THE ROTAWIRE DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215396 ↗
• MalfunctionJul 13, 2021Entrapment of Device; Failure to Advance; Output Problem; Intermittent Loss of Power; Entrapment of Device; Failure to Advance; Output Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE ROTAWIRE BECAME STUCK TO THE ROTAPRO CATHETER. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A ROTAWIRE AND ROTAPRO CATHETER WERE SELECTED TO TREAT THE LESION. POST ABLATION THE DEVICES WERE ATTEMPTED TO BE REMOVED IN DYNAGLIDE MODE. THERE WAS SEVERE RESISTANCE AND THE DEVICES WERE STUCK TOGETHER. AS THE DEVICES WERE BEING REMOVED AT A LOWER ROTATIONAL SPEED THE SYSTEM STALLED. THE ROTAWIRE AND ROTAPRO CATHETER WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160666 ↗
• MalfunctionJun 2, 2021Entrapment of Device; Entrapment of Device

  IT IS REPORTED THAT A ROTAPRO AND ROTAWIRE ENTRAPMENT OCCURRED. A 1.75MM ROTAPRO AND A 300CM ROTAWIRE WERE SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE 90% STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS PREPARED OUTSIDE THE BODY AND PLATFORMED AT 180,000RPM, THEN ADVANCED OVER THE WIRE. DURING PROCEDURE, THE BURR BECAME STUCK ON THE WIRE INSIDE THE PATIENT. THE DEVICES WERE REMOVED TOGETHER AS ONE UNIT, AND SEVERE RESISTANCE WAS FELT DURING REMOVAL. AFTER IT WAS REMOVED, THE PHYSICIAN NOTICED THE ROTAWIRE WAS KINKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924617 ↗
• MalfunctionMay 18, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL ON THE BURR TIP. A 1.75MM ROTAPRO WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. DURING LOADING OF THE ROTAPRO ONTO THE GUIDEWIRE, DEBRIS WAS OBSERVED ON THE TIP OF THE BURR. THE BURR NEVER ENTERED THE PATIENT'S BODY. THE ROTAPRO WAS REMOVED AND EXCHANGED FOR ANOTHER OF THE SAME. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844772 ↗
• MalfunctionMay 13, 2021Entrapment of Device; Difficult to Remove; Failure to Advance; Intermittent Loss of Power; Entrapment of Device; Difficult to Remove; Failure to Advance; Intermittent Loss of Power

  IT WAS REPORTED THAT ENTRAPMENT ON THE GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED LEFT MAIN ARTERY. A 1.75 ROTAPRO AND A ROTAWIRE WERE SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI). DIFFICULTY OCCURRED ADVANCING THE BURR THROUGH THE GUIDE CATHETER; HOWEVER, THE BURR WAS ABLE TO BE DELIVERED TO THE LESION AND 2 OR 3 PASSES WERE SUCCESSFULLY MADE. IT WAS NOTED THAT THE SALINE TUBING MAY HAVE BEEN KINKED. THE DEVICE STALLED DURING THE NEXT ATTEMPT TO DELIVER THE BURR TO THE LESION WITH A SET SPEED OF 160,000 RPMS. WHILE IN DYNAGLIDE MODE, THE DEVICE STALLED AND THE ENTIRE SYSTEM WAS REMOVE TOGETHER AS ONE WITH THE GUIDEWIRE. THERE WERE NO ISSUE NOTED WITH THE TANK OR THE CONNECTIONS. A BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822230 ↗
• InjuryMay 7, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE BURR LIKELY CONTRIBUTED TO THE GUIDEWIRE FRACTURE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.75MM ROTAPRO AND A ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR A PERCUTANEOUS CORONARY INTERVENTION. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS ADVANCED THROUGH THE LESION IN THE LAD AND INTO THE DISTAL LAD. THE NON-BOSTON SCIENTIFIC GUIDEWIRE WAS EXCHANGED TO A ROTAWIRE USING A NON-BOSTON SCIENTIFIC MICROCATHETER. THE 1.75MM ROTAPRO WAS ADVANCED OVER THE ROTAWIRE AND ROTABLATION WAS PERFORMED ON THE PROXIMAL LAD. THE PHYSICIAN THEN DECIDED TO ROTABLATE DISTALLY IN THE MID LAD BUT WITH A SMALLER 1.5MM BURR. THE 1.75MM ROTAPRO WAS WITHDRAWN OVER THE ROTAWIRE USING DYNAGLIDE. A LARGE KINK WAS NOTED IN THE PROXIMAL END OF THE WIRE. DURING REMOVAL OF THE ROTAWIRE, A FRACTURE OCCURRED. AN OPTICROSS CATHETER VISUALIZED THAT APPROXIMATELY 2CM OF THE GUIDEWIRE TIP REMAINED ENTIRELY IN THE SMALL SEPTAL ARTERY AND AS SUCH COULD NOT BE SNARED. THE REMAINING ROTAWIRE WAS WITHDRAWN. THE PROCEDURE WAS CONTINUED WITH A NEW ROTAWIRE AND A 1.5MM ROTABLATOR. ROTABLATION WAS PERFORMED

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11790280 ↗
• MalfunctionApr 30, 2021Output Problem; Noise, Audible; Output Problem; Noise, Audible

  IT REPORTED THAT THERE WAS UNSTABLE SPEED. A 1.75MM ROTAPRO WAS SELECTED FOR ATHERECTOMY PROCEDURE. THE ROTAPRO WAS PREPPED AND PLATFORMED AT 165,000 RPM OUTSIDE THE PATIENT, THEN ADVANCED OVER THE WIRE, AND CROSSED THE LESION. DURING THE PROCEDURE, THE DEVICE HAD AN ABNORMAL SOUND AND THE ROTATIONAL SPEED INCREASED ABOVE 200,000 RPM. THE PROCEDURE WAS STOPPED AND THE BURR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ANOTHER ROTAPRO DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753036 ↗

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-0916-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
• Z-0915-2022 · Mar 8, 2022 · Open, Classified
  ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
• 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
• 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