ROTAPRO™ H749393001250Recalls & reported problems

Summary

The FDA's MAUDE database contains 573 adverse event reports that list this exact device (DI 08714729893356), received between Feb 6, 2019 and Nov 8, 2024 — classified as 22 deaths, 106 injuries, 445 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (247 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 573 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATION SPEED WAS SET AT 140,000RPM; HOWEVER, UNSTABLE SPEED OCCURRED WITH A RANGE OF 120,000 TO 180,000RPM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641525 ↗
• MalfunctionOct 30, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.75MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK ON WIRE DUE TO POOR SLIDING WITH THE WIRE. THE DEVICES WERE COMPLETELY REMOVED, AND THE PROCEDURE WAS CONTINUED AND COMPLETED WITH A CUTTING BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569506 ↗
• MalfunctionOct 30, 2024Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS STUCK IN LESION.THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR GOT STUCK IN LESION. THE DEVICE WAS REMOVED BY USING THE GUIDE CATHETER. 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 20568777 ↗
• MalfunctionOct 30, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE ROTATION SPEED WAS UNSTABLE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 1.50 MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTATION SPEED WAS UNSTABLE RANGING FROM 170K - 220K RPM WHICH EXCEEDED THE SET OPERATIONAL SPEED OF 180K RPM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568676 ↗
• InjuryOct 28, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN LESION. THE TARGET LESION WAS LOCATED IN THE VERY TIGHT CALCIFIED ARTERY. A 1.50 MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTAPRO BURR GOT STUCK IN THE LESION AND WAS CUT TO RELEASE. THE BURR WAS RECOVERED USING A GUIDEZILLA 8FR CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE AND A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544288 ↗
• InjuryOct 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BURR DETACHMENT OCCURRED. A 1.50 MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR GOT SEPARATED. THE LESION AREA WAS DILATED WITH A BALLOON CATHETER, AND THE BURR WAS RETRIEVED INSIDE THE GUIDING CATHETER WITH A SNARE. NO FRAGMENTS REMAINED INSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514593 ↗
• MalfunctionOct 21, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTATION SPEED WAS UNSTABLE, AND IT INCREASED AND DECREASED. THE SET ROTATION SPEED WAS 180,000RPM AND THE MAXIMUM NUMBER OF ROTATIONS OBSERVED WAS AT 190,000RPM WITH AN UNSTABLE SPEED RANGE OF 170,000 TO 190,000RPM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495944 ↗
• MalfunctionOct 21, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK HAS OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS LEAKING SALINE. 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 20495869 ↗
• MalfunctionOct 21, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INNER BAG WAS TORN. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 2.00MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE INNER BAG WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495630 ↗
• MalfunctionOct 18, 2024Entrapment of Device; Output Problem; Entrapment of Device; Output Problem

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. A 1.75MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTATION SPEED WAS NOT STABLE, AND IT ONLY INCREASES FOR ABOUT 5000 RPM. CONSECUTIVELY, THE WIRE GOT STUCK WITH THE BURR DURING DYNAGLIDE MODE. THE DEVICE WAS REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS GOOD AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481763 ↗
• InjuryOct 16, 2024Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN LESION, GUIDEWIRE DETACHMENT OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 1.25MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER REACHING THE LESION, ROTABLATION WAS PERFORMED BUT WAS INEFFECTIVE AS BURR BECAME STUCK IN LESION. THE BURR WAS REMOVED AS A SYSTEM, MOTHER-IN-CHILD SYSTEM TECHNIQUE, BUT THE ROTAWIRE BREAKS DOWNSTREAM OF THE BURR. AT THE END OF THE PROCEDURE, CORONARY DISSECTION AT THE LEVEL OF THE OCCLUSION WITH A 2 CM PERICARDIAL EFFUSION WAS NOTED AND PERICARDIOCENTESIS WAS PERFORMED.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 20462785 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A LIQUID LEAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS LEAKING LIQUID. 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 20450133 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WATER LEAKED FROM THE DEVICE. A 1.75MM ROTAPRO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT WATER LEAKED FROM THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441192 ↗
• MalfunctionOct 8, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR GOT STUCK ON THE GUIDEWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 1.25MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING REMOVAL, IT WAS NOTED THAT THE WIRE GOT KINKED APPROXIMATELY 2CM FROM THE PROXIMAL PART OF THE WIRE. CONSEQUENTLY, THE BURR GOT STUCK ON THE GUIDEWIRE. THE BURR AND ROTAWIRE WERE REMOVED FROM THE BODY AS ONE UNIT. 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 20402173 ↗
• MalfunctionOct 7, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN TRUNK UP TO PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND ANOTHER 3.25MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION STILL, DURING THE SECOND INFLATION FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS ALSO REMOVED, AND A NEW 3.50MM X 15MM NC EMERGE BALLOON CATHETER WAS ADVANCED BUT, DURING THE SECOND INFLATION FOR 10 SECONDS, THE BALLOON ALSO RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. A DIFFERENT DEVICE WAS USED TO COMPLETE THE DILATATION PROCESSED. DURING THE SAME PROCEDURE, A 1.50MM ROTAPRO AND ROTAWIRE WAS SELECTED FOR USE. THE ROTATION SPEED DURING INSERTION WAS SET AT 190,000 RPM AND THE MAXIMUM SPEED WAS ALSO AT 190,000 RPM. HOWEVER, THE BURR GOT STUCK WITH THE WIRE AND COULD NOT BE RELEASED. THE ROTAPRO BURR AND THE ROTAWIRE WERE REMOVED AS ONE UNIT OUTSIDE THE PATIENT. THEN, A SECOND ROTAPRO WAS USED TO ABLATE THE L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384172 ↗
• MalfunctionOct 3, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN LESION. ALSO, THE BURR BECAME STUCK ON WIRE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM ROTAPRO AND ROTAWIRE DRIVE WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, AT THE FIRST ABLATION, THE RPM DROPPED BY 5,000. THE ENTRY POINT WAS SLIGHTLY ABLATED, AND ON THE SECOND ATTEMPT, FURTHER ABLATION WAS PERFORMED DEEPER, BUT THE DEVICE GOT PULLED INTO THE CALCIFIED LESION AND BECAME STUCK. WITH FORCEFUL PULLING, IT WAS RETRIEVED. THE WIRE HAD LODGED INTO THE TIP AND CAME OUT TOGETHER. THE ENTRAPMENT WAS STRONG, AND IT COULD NOT BE REMOVED OUTSIDE THE BODY, SO REUSE WAS ABANDONED. BOTH THE CATHETER AND WIRE WERE REPLACED TO CONTINUE. THE NEW ONES WERE USED WITHOUT ANY ISSUES. BOTH THE WIRE AND THE BURR WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY COMPLETELY BY PULLING WITH A LITTLE FORCE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363047 ↗
• MalfunctionOct 2, 2024Entrapment of Device; Material Deformation; Intermittent Loss of Power; Entrapment of Device; Material Deformation; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE WIRE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 1.50MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BURR QUIT SPINNING AND LODGED ON THE WIRE. THE BURR AND THE WIRE WERE REMOVED TOGETHER FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354904 ↗
• MalfunctionOct 1, 2024Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. A 2.00MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE HAS STALLED AT 180,000 RPM ON THE FIRST ATTEMPT. SINCE IT DID NOT FUNCTION AFTER THAT, DEVICE WAS REMOVED TOGETHER WITH THE WIRE. 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 20344518 ↗
• MalfunctionSep 30, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MATERIAL DAMAGE OCCURRED. A 1.50MM ROTAPRO WAS SELECTED FOR ROTABLATION. DURING PROCEDURE, THE COVER OF THE WIRE STARTED MELTING OR BEING DAMAGED BECAUSE OF THE ROTATIONS OF THE WIRE. THE DEVICE WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333910 ↗
• MalfunctionSep 18, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON THE WIRE. THE 78% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 1.50MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTAPRO BURR COULD NOT BE REMOVED AS IT WAS STUCK ON THE ROTAWIRE. THE DEVICES WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251457 ↗
• MalfunctionSep 18, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS ENTRAPPED WITH THE GUIDEWIRE. A 1.25MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE. DURING ROTATION TESTING INSIDE THE PATIENT, THE ROTAPRO BURR BECAME STUCK ON THE ROTAWIRE. THE ROTAPRO BURR AND ROTAWIRE WERE REMOVED AS ONE UNIT OUTSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247601 ↗
• MalfunctionSep 16, 2024Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23AUG2024. IT WAS REPORTED THAT THE BURR COULD NOT PASS THROUGH THE GUIDE CATHETER TIP SECTION. A 2.25MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR COULD NOT PASS THROUGH THE GUIDE CATHETER TIP. THE DEVICE WAS REMOVED BY NORMAL EXTRACTION METHOD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL AND SHEATH WERE DETACHED ON THE PROXIMAL END OF THE BURR CATHETER AT 82CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226186 ↗
• MalfunctionSep 16, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON GUIDEWIRE. A 1.50 ROTAPRO AND ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHEN REMOVING THE BURR, IT COULD NOT SLIDE OVER THE GUIDEWIRE. THE GUIDEWIRE HAD TO BE REMOVED TOGETHER WITH THE BURR AND A NEW GUIDEWIRE WAS INSERTED IN ITS PLACE. PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223619 ↗
• 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 20207514 ↗
• MalfunctionSep 12, 2024Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. A 1.25MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTAPRO BURR COULD NOT BE BROUGHT OVER THE WIRE TO THE TARGET LESION. THE SYSTEM WAS BLOCKED, AND EVERYTHING HAD TO BE TAKEN OUT. THE BURR AND WIRE COULD NOT BE REMOVED SEPARATELY WHEN OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206564 ↗

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-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