RotaLink™ Plus H749236310050Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729316442), received between Dec 16, 2016 and Mar 29, 2022 — classified as 5 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (18 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE BURR BECAME STUCK ON THE GUIDEWIRE. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A SEVERELY CALCIFIED LESION. A ROTOBLATOR ROTALINK PLUS 2.00MM AND ROTAWIRE WERE BEING USED FOR TREATMENT. DURING THE PROCEDURE, THE PHYSICIAN HAD NOTICED THE ROTABURR AND ROTAWIRE WERE STUCK TOGETHER. THE PHYSICIAN COULD NOT RELEASE THE DEVICES, SO THEY WERE REMOVED TOGETHER AND REPLACED WITH SIMILAR DEVICES. THE NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13937636 ↗
• MalfunctionJan 13, 2022Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE ROTAWIRE WAS STUCK WITH THE ROTABLATOR. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.00MM ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE ABLATION, THE DEVICE WAS TRAPPED NEAR THE 7FR NON BOSTON SCIENTIFIC GUIDE CATHETER TIP WHEN TRYING TO RECOVER THE BURR. IT WAS ALSO NOTED THAT THE DEVICE WAS STUCK IN THE ROTAWIRE. RESISTANCE WAS FELT SO THE DEVICES WERE REMOVED ALL TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253312 ↗
• MalfunctionAug 10, 2021Output Problem; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE ROTATION SPEED WAS UNSTABLE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE FAILED TO REACH THE TARGET ROTATION SPEED OF 200,000 RPM. THE ACTUAL ROTATION SPEED REACHED WAS AT 120,00RPM. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHEATH TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304666 ↗
• MalfunctionJan 19, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BURR WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDE CATHETER WAS KINKED AND THE BURR WAS DIFFICULT TO REMOVE. THE DEVICE WAS REMOVED TOGETHER WITH THE WHOLE SYSTEM. THE GUIDE CATHETER WAS CHANGED AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 11197676 ↗
• MalfunctionDec 15, 2020Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE BURR WAS DIFFICULT TO REMOVE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION WITH 7 ABLATIONS PERFORMED. RESISTANCE WAS FELT DURING RETRIEVAL IN DYNAGLIDE MODE. THE DEVICE WAS SIMPLY PULLED OUT AND COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY ADDITIONAL INTERVENTION AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11011885 ↗
• MalfunctionSep 28, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE. WHEN THE BURR WAS TRIED TO BE REMOVED, IT DID NOT COME OUT AND BECAME UNABLE TO BE PULLED. THE ROTALINK WAS PULLED OUT TOGETHER WITH THE ROTAWIRE WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. AFTER REMOVING THE DEVICES FROM THE PATIENT, THE ROTAWIRE WAS REMOVED FROM THE ROTALINK BURR. THERE MIGHT BE RESISTANCE WHEN PULLING THE ROTAWIRE OUT FROM THE ROTALINK. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED WITHOUT ANY PROBLEM. IT WAS FURTHER REPORTED THAT NO FRAGMENTS WERE REMAINED IN THE PATIENT. THE PATIENT WAS ALREADY DISCHARGED FROM THE HOSPITAL WITHOUT ANY HEALTH INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593428 ↗
• MalfunctionSep 10, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE WIRE SLIPPED BEHIND THE BURR AND FELL BACK. THE TARGET LESION AREA WAS LOCATED IN SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.00MM ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING DYNAGLIDE MODE, ROTABURR WORKED NORMALLY. HOWEVER, THE ROTAWIRE MOVED OUT OF THE LAD LESION AND IT WAS NOTED THAT IT WAS SLIPPING BEHIND THE ROTALINK PLUS AND FELL BACK DURING ENGAGEMENT OF THE ROTABURR TO THE LESION WHILE ON DYNAGLIDE MODE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515778 ↗
• MalfunctionJul 2, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, AFTER ABLATION WAS PERFORMED BY A 1.5MM BURR, THE SIZE WAS INCREASED TO 2.00MM. HOWEVER, THE BURR GOT STUCK UPON CROSSING THE LESION AND WAS SUCCESSFULLY REMOVED BY DEEPLY ENGAGING THE GUIDING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224372 ↗
• MalfunctionMay 22, 2020Unstable; Unstable

  IT WAS REPORTED THAT ROTATION SPEED WAS UNSTABLE. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE HAD UNSTABLE ROTATION SPEED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10082671 ↗
• MalfunctionApr 21, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE BURR. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE ALONG WITH A ROTAWIRE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS DIFFICULTY REMOVING THE BURR DUE TO RESISTANCE WITH THE ROTAWIRE. THE BURR WAS REMOVED FROM THE PATIENT INDEPENDENTLY OFF THE WIRE. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9982633 ↗
• MalfunctionMar 17, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT BURR TO HANDSHAKE CONNECTION WAS BROKEN. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, THE ADVANCER KNOB SEEMED TO BE HARD TO MOVE. UPON ADVANCING THE WIRE THROUGH THE BURR TIP, THE WIRE GOT STUCK IN THE BURR TIP AND COULD NOT ADVANCE ANY FURTHER. WHEN THE DEVICE WAS REMOVED, A BREAK WAS NOTED BETWEEN THE END OF THE BURR TIP ABOUT 2CM BEFORE THE HANDSHAKE CONNECTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9843633 ↗
• MalfunctionMar 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ROTALINK GOT SEPARATED. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE COULD NOT BE INSERTED IN TO THE BURR AND WAS NOTED THAT THE ROTALINK GOT SEPARATED OUTSIDE OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835345 ↗
• MalfunctionMar 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUSH COCKTAIL LEAKED. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE FLUSH COCKTAIL LEAKED HALFWAY UP THE CATHETER AND THERE WAS A HOLE. THE FLUSH COCKTAIL WOULD NOT GO THROUGH THE CATHETER. IT WAS NEVER USED INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793160 ↗
• MalfunctionFeb 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BURR SEPARATION OCCURRED. A 2.00MM ROTALINK PLUS WAS USED FOR TREATMENT IN THE CORONARY ARTERY. DURING PROCEDURE, ROTATIONAL BURR SEPARATION WAS NOTED, THE DEVICE WAS THEN REMOVED TOGETHER WITH THE ROTAWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706431 ↗
• MalfunctionFeb 5, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION AND THE DRIVE SHAFT SHEATH DETACHMENT OCCURRED. THE 90% STENOSED, 24MM X3.0MM TARGET LESION WAS IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 7F GUIDE CATHETER WAS IN USE WITH A 1.5MM ROTABURR. THE BURR WAS UPSIZED TO A 2.0MM ROTALINK PLUS AND ABLATION WAS PERFORMED OVER 150,000 RPM WITHIN 20 SECONDS EACH ABLATION. THE BURR THEN BECAME STUCK IN THE LESION DUE TO THE LESION CHARACTERISTICS. CONSEQUENTLY, THE SHAFT WAS CUT AND THE 7F GUIDE CATHETER WAS DEEP SEATED IN ATTEMPTS TO REMOVE THE BURR. DURING WITHDRAWAL, THE DRIVE SHAFT SHEATH COULD NOT BE REMOVED AND EVENTUALLY THE DRIVE SHAFT SHEATH DETACHED AS A RESULT OF CONTINUOUS PULLING. EVENTUALLY THE DEVICE WAS REMOVED TOGETHER WITH THE SYSTEM WITHOUT ANY FRAGMENTS LEFT UNRETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673239 ↗
• InjurySep 3, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT BURR SEPARATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE AND THE BURR BECAME STUCK WITHIN THE LESION. DURING REMOVAL THE BURR BECAME SEPARATED. SUBSEQUENTLY, INFLATION WAS PERFORMED AT THE PROXIMAL PART AND THE BURR WAS SUCCESSFULLY RETRIEVED VIA A SNARING. THE PROCEDURE WAS COMPLETED WITH NON BSC DEVICE. NO COMPLICATIONS WERE REPORTED. PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8956610 ↗
• MalfunctionSep 3, 2019Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THERE WERE TWISTING AND BURNT ON THE OUTER SHEATH. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE FUNCTIONAL TESTING IT WAS NOTED THAT THE OUTER SHEATH WAS TWISTED AND BURNT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8956493 ↗
• MalfunctionJul 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR DETACHED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 2.0MM ROTALINK PLUS WAS SELECTED FOR USE. AFTER ABLATION, RESISTANCE WAS FELT WHEN THE BURR WAS PULLED UPON REMOVAL AND GOT DETACHED AT THE BOUNDARY BETWEEN THE ROTATING BURR AND DRIVESHAFT. THE DETACHED BURR WAS THEN REMOVED BY INSERTING A GUIDEZILLA AND A NEW WIRE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831344 ↗
• MalfunctionJul 16, 2019Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT SHAVINGS CAME OUT FROM THE BURR. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING PREPARATION, RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE ROTAWIRE INTO THE ROTABURR. SUBSEQUENTLY, OBJECTS LIKE SHAVINGS CAME OUT FROM THE TIP OF THE BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795969 ↗
• MalfunctionJun 19, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR AND WIRE BECAME STUCK. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 2.0MM ROTALINK PLUS AND A 330CM ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, AFTER ROTATION TEST OUTSIDE THE PATIENT'S BODY, THE BURR WAS ADVANCED INSIDE THE GUIDING CATHETER. HOWEVER, THE BURR GOT STUCK IN THE GUIDING CATHETER BEFORE THE SECONDARY CURVE. SUBSEQUENTLY, THE WIRE AND BURR GOT STUCK AND COULD NOT BE ADVANCED OR RETURNED. THE BURR WAS THEN REMOVED TOGETHER WITH THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8713714 ↗
• MalfunctionApr 8, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DRIVE SHAFT FRACTURED. A 75% STENOSED TARGET LESION WAS LOCATED AT THE OSTIUM PART OF THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 1.75MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS DIFFICULTY ENGAGING THE 7F GUIDE CATHETER. THE 1.75 ROTABURR WAS USED FOR ABLATION FOUR TIMES DURING PROCEDURE AT 200,000RPM. THEN, IT WAS REMOVED AND REPLACED BY A 2.0 MM ROTABURR. THE 2.0MM ROTABURR WAS ALSO USED FOR ABLATION FOUR TIMES AT 200,000RPM. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE ROTABURR BUT THE TIP BECAME STUCK AT THE ENTRANCE OF THE GUIDING CATHETER. THE ROTABURR WAS PULLED BUT IT DID NOT COME OUT WITH THE BURR PART ON THE TIP. WHEN PULLING THE WIRE, THE BURR ENTERED INSIDE THE GUIDING CATHETER, SO THE ENTIRE SYSTEM WAS REMOVED TOGETHER. THE BURR WAS CONFIRMED TO BE SEPARATED AFTER INSPECTING OUTSIDE OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING BALLOON INFLATION AND STENT PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492064 ↗
• MalfunctionMar 11, 2019Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT A BURR BECAME STUCK ON THE ROTAWIRE. A 2.00MM ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, WHEN DELIVERING THE BURR TO THE LESION, RESISTANCE WAS NOTED. CONSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE BURR; HOWEVER, IT COULD NOT BE PULLED AND WAS TRAPPED AND UNUSUAL SOUND WAS HEARD. THEN, THE BURR WAS REMOVED TOGETHER WITH THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH A 1.75MM ROTALINK PLUS AND NEW ROTAWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408641 ↗
• InjuryFeb 27, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE ABLE TO PASS THE TARGET LESION. HOWEVER, IT BECAME STUCK IN THE LESION. THE BURR WAS RELEASED FROM BEING STUCK THROUGH SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT IS STABLE.

  Patient problems: No Code Available

  MAUDE report 8374432 ↗
• MalfunctionFeb 20, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. THE 25MM, 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. A 2.00MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE OPERATIONAL SPEED OF THE BURR WAS SET AT 190,000RPM. THE ROTATIONAL SPEED FOR EACH ABLATION WAS AT 160,000 TO 170,000RPM FOR 10 SECONDS. AT THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK AND PENETRATED IN THE DISTAL PART OF THE TARGET LESION AS THE AREA WAS TIGHT. FURTHERMORE, THE BURR WAS DIFFICULT TO REMOVE. CONSEQUENTLY, A NON BSC 6F GUIDE CATHETER WAS INSERTED WITH A NON BSC GUIDEWIRE AND BALLOONING WAS PERFORMED WITH A 3.0X12MM NON BSC BALLOON IN THE PROXIMAL PART OF THE AREA WHERE THE BURR WAS STUCK AND THEN THE BURR WAS EVENTUALLY RELEASED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354187 ↗
• MalfunctionFeb 5, 2019Device Damaged by Another Device; Physical Resistance/Sticking; Device Damaged by Another Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT A ROTAWIRE FRACTURE OCCURRED. A 2.00MM ROTALINK PLUS AND A 330CM ROTAWIRE WERE SELECTED FOR USE. DURING PREPARATION, WHEN THE ROTATIONAL SPEED WAS BEING SET, IT WAS NOTED THAT THE ROTAWIRE BECAME SEPARATED. THEN, ANOTHER ROTAWIRE WAS USED; HOWEVER, THE BURR WAS UNABLE TO LOAD INTO THE WIRE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8306702 ↗

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