ROTAPRO™ H749393001500Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 08714729893363), received between Nov 12, 2018 and May 7, 2025 — classified as 2 deaths, 26 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (63 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 142 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED, REQUIRING AN ADDITIONAL DEVICE TO REMOVE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAPRO BURR BECAME STUCK IN THE LESION. AN ATTEMPT WAS MADE TO PULL TO REMOVE THE ROTAPRO BURR; HOWEVER, IT WAS NOT SUCCESSFUL. A SECOND PHYSICIAN ALSO ATTEMPTED TO REMOVE, WITHOUT SUCCESS. THE ROTAPRO ADVANCER BODY AND DRIVESHAFT WERE CUT TO REMOVE THE OUTER SHEATH TO EXPOSE THE DRIVESHAFT. THE PROCEDURE WAS COMPLETED, AND THE DEVICE WAS SUCCESSFULLY REMOVED BY ADVANCING A NON-BOSTON SCIENTIFIC GUIDE CATHETER EXTENSION OVER THE BURR. THE WIRE AND ROTAPRO BURR WERE REMOVED TOGETHER, HOWEVER THEY WERE NOT ENTANGLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976370 ↗
• InjuryApr 21, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT BURR GOT STUCK ON LESION AND WAS NOT RETRIEVED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH DIFFUSE DISEASE. A 1.5 MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN MADE FOUR PASSES IN THE MIDDLE RIGHT CORONARY ARTERY AND ON THE FIFTH PASS, THE BURR GOT DISLODGED IN THE LESION. THE PHYSICIAN TRIED USING A BUDDY WIRE TO DISLODGE AND PULL BUT THE BURR DID NOT MOVE. THE PHYSICIAN CUT THE BURR FROM THE ADVANCER AND RAIL THE GUIDEZILLA OVER THE BURR. BUT IT WAS STILL NOT MOVING. THEY TRIED PULLING HARDER AND THE BURR BROKE AT THE DRIVESHAFT. THEY WERE ABLE TO WIRE PAST THE BURR AND CONTINUED TO TREAT THE VESSEL WITH BALLOONING. THEY USED AN IVUS CATHETER DOWN AND USED SHOCKWAVE. AFTER DOING SO, A HAZY OR DISSECTED AREA WAS NOTED, WHICH PROMPTED THEM TO STENT THE RCA OVER THE DISLODGE BURR. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. THE DEVICE WAS ADVANCE IN A 16,000RPM SET SPEED AND REACHES THROUGH A NORMAL RPM IN AN APPROPRIATE TECHNIQUE. HOWEVE

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 21875283 ↗
• MalfunctionMar 24, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR STUCK IN THE LESION. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 50% STENOSED, 3.5MM DIAMETER, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND HEAVILY CALCIFIED DISTAL LEFT MAIN (LM) TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.5MM ROTAPRO WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THE BURR WAS STUCK IN THE DISTAL LM. ANOTHER WIRE WAS PLACED IN THE VESSEL PARALLEL TO THE ROTAWIRE TO DELIVER A BALLOON WHICH WAS INFLATED TO FREE THE STUCK BURR. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21683988 ↗
• MalfunctionFeb 13, 2025Entrapment of Device; Difficult to Remove; Device-Device Incompatibility; Intermittent Loss of Power; Entrapment of Device; Difficult to Remove; Device-Device Incompatibility; Intermittent Loss of Power

  IT WAS REPORTED THAT THE DEVICES WERE DIFFICULT TO REMOVE, REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, DIFFICULTY IN PASSING THE BALLOONS AND GETTING THEM TO EXPAND WELL WAS ENCOUNTERED. A NON-BOSTON SCIENTIFIC (NON-BSC) STENT WAS PLACED IN THE PROXIMAL PORTION OF THE RIGHT CORONARY ARTERY. FOLLOWING PLACEMENT, ROTA WAS ATTEMPTED IN THE MIDDLE PORTION. DURING THE PROCEDURE, WHEN THE ROTA PORTION OF THE PROCEDURE WAS COMPLETED, AN ATTEMPT WAS MADE TO REMOVE THE BURR, HOWEVER THE ROTAPRO BURR BECAME STUCK ON THE EDGE OF THE STENT. A SECOND WIRE WAS USED TO ATTEMPT AND BALLOON TO THE EDGE OF THE STENT TO ALLOW THE BURR TO EXIT, HOWEVER, THE WIRE COULD NOT PASS THROUGH THE STENT. IT APPEARED THAT THE OTHER WIRE WAS FRAYED ON TO THE BURR WHEN AN ATTEMPT WAS MADE TO PASS A WIRE UP TO BALLOON TO THE EDGE OF THE STENT. THE ROTAPRO BURR WAS CUT OFF OF THE ADVANCER. A GUIDE EXTENSION WAS THEN USED TO MITIGATE AND THAT ALSO WOULD NOT PASS. THE GUIDE WAS THEN REMOVED, THE FRAYED PIECE WAS PULLED OFF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381708 ↗
• MalfunctionDec 31, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SHAFT LEAK OCCURRED. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, A LEAK WAS NOTED IN THE MIDDLE OF THE CATHETER TUBE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048163 ↗
• MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR DETACHED. A 1.50MM ROTAPRO WAS SELECTED FOR ROTATIONAL ATHERECTOMY. DURING PREPARATION, THE PACKAGE WAS OPENED AND THE ADVANCER WAS CONNECTED TO THE CONSOLE. THE TEST WAS CONDUCTED WHEN THE ADVANCER WAS UNABLE TO BE ADVANCED TO THE CONDUCTOR AND IT WAS FOUND THAT THE DRILL DETACHED FROM THE SHAFT AND REMAINED ON THE CONDUCTOR, LIQUIDS WERE FED THE FREQUENCY OF ROTATION AT FIRST FELL BY 10 THOUSAND REVOLUTIONS BUT THEN RECOVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527179 ↗
• MalfunctionSep 27, 2024Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT THE SHEATH LEAK OCCURRED. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, A BLOOD WAS NOTED ON THE BURR CATHETER SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321929 ↗
• MalfunctionSep 26, 2024Adverse 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 ON (B)(6) 2024. IT WAS REPORTED THAT DEVICE STALLED. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING PREPARATION PRIOR TO PROCEDURE THE ROTAPRO WAS NOT WORKING WELL AND SHOWING RED STALL INDICATOR ERROR. PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT CATHETER COIL AND SHEATH WERE DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313729 ↗
• MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26AUG2024. IT WAS REPORTED THAT LEAK OCCURRED. A 1.50MM ROTAPRO WAS SELECTED FOR PCI PROCEDURE, DURING PREPARATION, LEAK OF SALINE SOLUTION ON ADVANCER ON TIP FROM ADVANCER TO BURR WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE SHEATH WAS TORN AND BLOOD WAS VISIBLE ON THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251643 ↗
• MalfunctionSep 12, 2024Entrapment of Device; Output Problem; Intermittent Loss of Power; Entrapment of Device; Output Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A 1.50MM, 1.25MM ROTAPRO AND CONSOLE WERE SELECTED FOR USE. DURING PREPARATION, THE 1.50MM BURR STALLED BRIEFLY. WHEN IT WENT INTO THE PATIENT WITH A SET SPEED OF 165K. THE SPEED REACHED AT A MAXIMUM OF 200K, AND IT STALLED MULTIPLE TIMES AND WOULD NO LONGER RUN AS IT STUCK IN THE PROXIMAL LESION. THE DEVICE WAS REMOVED FROM THE BODY AND WAS CHANGED TO A 1.25 BURR. WHEN PLACED PRIOR TO THE LESION AT A SET SPEED OF 165K. THE ROTATION SPEED PER MINUTE (RPM) APPEARED ON THE SCREEN WITH A MAXIMUM 0F 220K, BUT NO SOUND OF THE BURR WAS HEARD, AND NO STALLED SIGNAL WAS ON. THE BURR WAS ALSO GOT STUCK IN THE LESION. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THE PROCEDURE GOT PROLONGED, BUT NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20205288 ↗
• InjuryJun 18, 2024Entrapment of Device; Material Separation; Stretched; Detachment of Device or Device Component; Mechanical Jam; Entrapment of Device; Material Separation; Stretched; Detachment of Device or Device Component; Mechanical Jam

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND PATIENT UNDERWENT SURGERY. A 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS OSTIAL CIRCUMFLEX ARTERY. A 1.50 ROTABURR WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN TRYING TO EXIT THE WIRE THROUGH THE PROXIMAL END OF THE ADVANCER. UPON REMOVING THE WIRE, IT WAS NOTED TO BE A LITTLE KINKED IN THE PROXIMAL TIP OF THE WIRE. THE BENT WAS MODIFIED, AND PROGRESS WAS MADE WITHOUT PROBLEM. ABLATION WAS COMPLETED WITHOUT COMPLICATIONS HOWEVER, THE PHYSICIAN NOTICED THAT THERE WAS RESISTANCE. WHEN TRYING TO REMOVE THE BURR, THE GUIDE CATHETER LOST ITS OSTIAL POSITION IN HIS OPINION. THE PROXIMAL PART OF THE BURR WAS STUCK TO THE AORTA AND DID NOT ALLOW THE GUIDE CATHETER TO BE REINSERTED. THEY TRIED TO SNARE WITHOUT SUCCESS. PING PONG WAS ATTEMPTED WITH A SECOND WIRE, MANAGING TO CHANNEL AGAIN SUCCESSFULLY, BUT WITHOUT SUCCESS IN REMOVING THE BURR. OTHER OPTIONS WERE STOPPED, AND BY-PASS SURGERY WAS PERFORMED.

  Patient problems: Discomfort; Vascular Dissection

  MAUDE report 19556960 ↗
• MalfunctionApr 8, 2024Difficult to Flush; Adverse Event Without Identified Device or Use Problem; Output Problem; Noise, Audible; Physical Resistance/Sticking; Difficult to Flush; Adverse Event Without Identified Device or Use Problem; Output Problem; Noise, Audible; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE ROTATION SPEED WAS NOT STABLE. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING ROTABLATION, THE ADVANCER WAS STUCK IN THE MIDDLE AND WAS UNABLE TO MOVE DISTALLY. ADDITIONALLY, THERE WAS NO DROP IN SPEED ON THE CONSOLE. AN UNEXPECTED NOISE WAS HEARD. THE SET OPERATIONAL SPEED WAS 160K TO 180K RPM HOWEVER, THE MAXIMUM SPEED REACHED WAS190K RPM. THE ROTAPRO BURR WAS REMOVED AND ATTEMPTED TO BE FLUSHED, BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT ROTAPRO, AND THE SAME ROTAWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059899 ↗
• MalfunctionApr 3, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A STERILLITY ISSUE OCCURRED. A ROTAPRO 1.50MM WAS SELECTED FOR TREATMENT. DURING PREPARATION FOR THE PROCEDURE AS THE ROTAPRO WAS BEING OPENED, IT WAS NOTICED THAT THE PLASTIC STERILE BAG FOR THE DEVICE WAS DAMAGED. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037640 ↗
• MalfunctionOct 23, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A ROTAPRO 1.50MM AND ROTAWIRE WERE SELECTED FOR USE DURING AN ANGIOPLASTY PROCEDURE. DURING ABLATION OF THE VERY CALCIFIC LESION, THE PHYSICIAN NOTED THAT THEY WERE NOT ABLE TO OVERCOME THE STENOSIS DUE TO NOT BEING ABLE TO INCREASE THE BURR ROTATIONS. THE BURR THEN BECAME ENTRAPPED ON THE ROTAWIRE RESULTING IN THE SYSTEM STALLING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992237 ↗
• MalfunctionOct 10, 2023Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. A 1.50MM ROTAPRO WAS SELECTED FOR USE TO TREAT THE SEVERELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADJUSTING THE SPEED WITH THE ROTAPRO AND THE ROTAPRO BURR BECAME STUCK IN THE LESION. THE ROTAPRO BURR WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH BALLOON DILATATION AND STENT IMPLANTATION. THE DEVICE WAS DISPOSED OF BY THE HEALTHCARE FACILITY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17904572 ↗
• MalfunctionOct 9, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR DETACHED RESULTING IN A PROLONGED PROCEDURE. DURING A ROTABLATION PROCEDURE, THE BURR STOPPED ROTATING. A BREAK BETWEEN THE BURR AND THE ADVANCER WAS NOTED AND THE BURR WAS RELEASED NEAR THE PROXIMAL RIGHT CORONARY ARTERY. THIS EVENT RESULTED IN MEDICAL DELAY AND INCREASED STRESS FOR THE PATIENT AND MEDICAL STAFF. HOWEVER, THE BURR WAS SUCCESSFULLY EXTRACTED FROM THE BODY AND THE PATIENT WAS REPORTEDLY FINE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17899596 ↗
• MalfunctionSep 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PLASTIC COVER OF THE ROTAPRO SHAFT WAS BROKEN. THE ROTAPRO WAS SUCCESSFULLY REMOVED FROM THE PATIENT TOGETHER WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTAPRO. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795126 ↗
• MalfunctionJul 17, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BURR DETACHMENT OCCURRED AND BECAME STUCK WITH THE GUIDEWIRE. A 1.50MM ROTAPRO WAS SELECTED FOR USE FOR A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE DRILL HEAD OF THE 1.50MM ROTAPRO CAME LOOSE AND DETACHED FROM THE SHAFT OF THE DEVICE WHEN IT WAS THREADED ONTO THE GUIDEWIRE. THE 1.50MM ROTAPRO DRILL HEAD REMAINED ON THE GUIDEWIRE. 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 17338158 ↗
• MalfunctionJul 7, 2023Difficult or Delayed Activation; Intermittent Loss of Power; Difficult or Delayed Activation; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A 1.50MM ROTAPRO AND A ROTAPRO CONSOLE WERE SELECTED FOR USE. DURING THE TEST PERIOD OUTSIDE THE PATIENT, THE ROTAPRO ADVANCER WAS CONNECTED TO THE ROTAPRO CONSOLE, BUT THE ADVANCER BUTTON FAILED TO ACTIVATE AND START THE ROTATION. THE ROTAPRO WAS STUCK BECAUSE OF THE BURR. CONSEQUENTLY, A STALL MESSAGE WAS DISPLAYED ON THE ROTAPRO CONSOLE. A NEW 1.50MM ROTAPRO ADVANCER WAS THEN USED, BUT THE SAME ISSUE WAS ENCOUNTERED. THE PROCEDURE WAS NOT COMPLETED AND WAS CONTINUED A DAY LATER WITH THE SAME CONSOLE WITH NO ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279009 ↗
• MalfunctionJul 7, 2023Difficult or Delayed Activation; Intermittent Loss of Power; Difficult or Delayed Activation; Intermittent Loss of Power

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A 1.50MM ROTAPRO AND A ROTAPRO CONSOLE WERE SELECTED FOR USE. DURING THE TEST PERIOD OUTSIDE THE PATIENT, THE ROTAPRO ADVANCER WAS CONNECTED TO THE ROTAPRO CONSOLE, BUT THE ADVANCER BUTTON FAILED TO ACTIVATE AND START THE ROTATION. THE ROTAPRO WAS STUCK BECAUSE OF THE BURR. CONSEQUENTLY, A STALL MESSAGE WAS DISPLAYED ON THE ROTAPRO CONSOLE. A NEW 1.50MM ROTAPRO ADVANCER WAS THEN USED, BUT THE SAME ISSUE WAS ENCOUNTERED. THE PROCEDURE WAS NOT COMPLETED AND WAS CONTINUED A DAY LATER WITH THE SAME CONSOLE WITH NO ISSUE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279006 ↗
• MalfunctionJun 15, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. A CORONARY ANGIOPLASTY WAS BEING PERFORMED USING A ROTAPRO 1.50MM AND ROTAWIRE FOR TREATMENT. WHILE USING DYNAGLIDE MODE TO REMOVE THE DEVICE, IT WAS NOTED THAT THE ROTAPRO BURR WAS STUCK ON THE ROTAWIRE AND COULD NOT MOVE ANYMORE. BOTH DEVICES WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138733 ↗
• MalfunctionJun 13, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. A CORONARY ANGIOPLASTY WAS BEING PERFORMED USING A ROTAPRO 1.50MM AND ROTAWIRE FOR TREATMENT. WHILE USING DYNAGLIDE MODE TO REMOVE THE DEVICE, IT WAS NOTED THAT THE ROTAPRO BURR WAS STUCK ON THE ROTAWIRE AND COULD NOT MOVE ANYMORE. BOTH DEVICES WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122510 ↗
• InjuryMay 24, 2023Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THE DEVICE WAS DIFFICULT TO ADVANCE AND ISCHEMIA, AND MYOCARDIAL INFARCTION OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE ROTAPRO WAS DIFFICULT TO ADVANCE AND THE KNOB DID NOT HAVE SMOOTH MOVEMENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. ISCHEMIA AND MYOCARDIAL INFARCTION WAS NOTED IN THE PATIENT, DURING THE DEVICE ISSUE. NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Ischemia; Myocardial Infarction

  MAUDE report 16991976 ↗
• MalfunctionMay 3, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AFTER THE PATIENT WAS SEDATED. A ROTAPRO 1.50MM WAS BEING USED AS A PART OF TREATMENT FOR A PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK WITHIN THE ADVANCER. THE PHYSICIAN THEN USED ANOTHER ROTAPRO 1.50MM TO ATTEMPT TO COMPLETE THE PROCEDURE. THE SECOND ROTAPRO 1.50MM THEN ALSO BECAME STUCK WITHIN THE ADVANCER. DUE TO BOTH DEVICES BECOMING STUCK WITHIN THE ADVANCER, THE PROCEDURE WAS POSTPONED FOR A LATER DATE. THE PATIENT WAS ALREADY SEDATED WHEN THE PROCEDURE WAS POSTPONED, HOWEVER NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864796 ↗
• MalfunctionMay 3, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AFTER THE PATIENT WAS SEDATED. A ROTAPRO 1.50MM WAS BEING USED AS A PART OF TREATMENT FOR A PROCEDURE. DURING PREPARATION FOR THE PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK. THE PHYSICIAN THEN USED ANOTHER ROTAPRO 1.50MM TO ATTEMPT TO COMPLETE THE PROCEDURE. THE SECOND ROTAPRO 1.50MM THEN ALSO BECAME STUCK. DUE TO BOTH DEVICES BECOMING STUCK, THE PROCEDURE WAS POSTPONED FOR A LATER DATE. THE PATIENT WAS ALREADY SEDATED WHEN THE PROCEDURE WAS POSTPONED, HOWEVER NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864794 ↗

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