Peripheral RotaLink® Plus M0011401250Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729857808), received between Jan 22, 2019 and Feb 19, 2024 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR WOULD NOT ADVANCE OR PULL BACK ON WIRE, LODGED IN CALCIFIED AREA AND BROKE IN HALF. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 1.25MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BURR WAS USED SUCCESSFULLY UNTIL IT DID NOT GO THROUGH A TIGHT CALCIFIED LESION. SUBSEQUENTLY, THE BURR WOULD NOT ADVANCE OR PULL BACK ON WIRE AND SEEMED TO HAVE LODGED IN CALCIFIED AREA; NOT ADVANCING FORWARD OR ON DYNA GLIDE. THE CATHETER AND WIRE WERE THEN PULLED OUT TOGETHER. AFTER REMOVAL, THE BURR WAS REMOVED INTACT BUT BROKE IN HALF (DUE TO CALCIFICATION). THE DETACHED PORTION CAME OUT WITH CATHETER, AND NOTHING WAS LEFT BEHIND. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730411 ↗
• InjuryJul 27, 2023Entrapment of Device; Noise, Audible; Intermittent Loss of Power; Entrapment of Device; Noise, Audible; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR STUCK WITH THE WIRE. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND 70% CALCIFIED TIBIAL AREA. A 1.25MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE MADE AN ABNORMAL SOUND AND IT STOPPED. THE BURR WAS STUCK AND COULD NOT COME OUT AS A WHOLE SYSTEM WITH WIRE. THE DEVICES WERE PULLED OUT USING A NON-BSC SUPPORT CATHETER. IT WAS REPORTED THE WIRE MAY HAVE DETACHED AND THE BURR WAS STUCK. THE DEVICES WERE REMOVED COMPLETELY FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANGIOPLASTY. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405899 ↗
• MalfunctionJan 9, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, STANDARD SET UP OF THE ROTABLATOR WAS PERFORMED AND SET THE SPEED TO 170K RPM. THE BURR WAS INSERTED TO THE LESION AND SEVERAL ATHERECTOMY RUNS WERE PERFORMED. HOWEVER, WHEN THE LAST RUN WAS PERFORMED, DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE BURR DETACHED FROM THE END OF THE ADVANCER. THE PHYSICIAN STATES THAT THE BURR NEVER STALLED OR STUCK AT ANY POINT. THE ROTABURR AND ROTAWIRE WERE GENTLY PULLED OUT TOGETHER WITHOUT INCIDENT. IN ADDITION, THE PATIENT HAD- AN ABNORMAL LFTS AND/OR BLOOD COUNTS BUT THE DEVICE OR PROCEDURE DID NOT CAUSE OR CONTRIBUTED TO THE PATIENT'S COMPLICATION ACCORDING TO THE PHYSICIAN'S OPINION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16127984 ↗
• MalfunctionSep 15, 2022Output Problem; Noise, Audible; Output Problem; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE EXCEEDED THE SET OPERATIONAL SPEED. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS MAKING UNEXPECTED NOISES WHEN THE PEDAL WAS DEPRESSED TO RUN THE DEVICE. ADDITIONALLY, THE DEVICE DID NOT APPEAR TO BE MOVING AS EXPECTED INSIDE THE VESSEL ON THE FLUOROSCOPY. SUBSEQUENTLY, THE SET OPERATIONAL SPEED WAS 176,000 RPM HOWEVER, THE MAXIMUM SPEED REACHED WAS AT 182,000 RPM. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429412 ↗
• MalfunctionMay 4, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON WIRE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 1.25MM PERIPHERAL ROTALINK PLUS AND A PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE. DURING WITHDRAWAL, THE BRAKE DEFEAT BUTTON AND THE DYNAGLIDE BUTTON WERE DEPRESSED TO BACK OUT THE ROTALINK SYSTEM OVER THE ROTAWIRE. HOWEVER, IT WAS NOTED THAT THE TECHNICIAN HAD A DIFFICULT TIME REMOVING THE ROTALINK BURR OVER THE ROTAWIRE. A WET STERILE SPONGE WAS USED AND IT BECAME A LITTLE EASIER TO REMOVE THE ROTALINK SYSTEM BACK OUT OVER THE ROTAWIRE. THE ROTAWIRE AND THE ROTALINK SYSTEM WERE REMOVED SIMULTANEOUSLY WITHOUT ANY OTHER COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282016 ↗
• MalfunctionFeb 15, 2022Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE BURR WAS DIFFICULT TO REMOVE AND WAS STUCK ON THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS NOT EASY TO ADVANCE AND RETRACT. CONSEQUENTLY, THE DEVICE WAS PULLED OUT USING DYNAGLIDE MODE AND MADE SURE THAT THE ROTAWIRE WAS NOT KINKED AND THE ROTAGLIDE WAS DRIPPING. THE DEVICE WAS REMOVED WITH THE WIRE STUCK IN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534298 ↗
• InjuryFeb 3, 2022Entrapment of Device; Noise, Audible; Entrapment of Device; Noise, Audible

  IT WAS REPORTED THAT THE BURR WAS STUCK ON WIRE. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, ADVANCEMENT WAS FINE, BUT WHEN THE DEVICE ENTERED THE DENSE PLAQUE, THE ADVANCER MADE A LOUD GRINDING NOISE SO THE PHYSICIAN STOPPED. THE DEVICE WAS REMOVED BUT IT GOT STUCK ON THE WIRE AND WOULD NOT COME OFF. THE BURR AND THE WIRE WERE PULLED OUT TOGETHER AND INTACT USING DYNAGLIDE MODE. A CONTRAST RUN WAS PERFORMED AFTERWARDS AND AN EXTRAVASATION OF THE VESSEL WAS FOUND. IT WAS UNCERTAIN IF IT WAS THE BURR OR THAT THE PATIENTS VESSEL WAS SO DISEASED THAT ACTUALLY CAUSED THE EXTRAVASATION. IT WAS NOTED THAT IT MIGHT HAVE BEEN THE PLAQUE AND THE BURR GOT TRAPPED AND COULDN'T SPIN AND GOT HUNG UP ON THE WIRE. A STERLING BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: Extravasation

  MAUDE report 13447929 ↗
• InjuryMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR BECAME DETACHED AND A SNARE CATHETER WAS USED TO RETRIEVE THE DETACHED FRAGMENT. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED LEFT DISTAL ANTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE BURR NEAR THE LOCATION OF THE TARGET LESION, SPUN ONCE AND NOTICED THAT THE BURR BROKE OFF WHEN TRYING TO ADVANCE FURTHER DOWN THE ANTERIOR TIBIAL ARTERY FOR MORE TREATMENT. A SNARE CATHETER WAS PLACED DOWN THE ROTAWIRE TO RETRIEVE THE BURR. AFTER COMPLETELY REMOVING THE BURR, THE PHYSICIAN JUST BALLOONED THE ARTERY. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829596 ↗
• 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 11617199 ↗
• InjuryMar 23, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE VESSEL. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE FOR AN ATHERECTOMY PROCEDURE TO TREAT THE PT DISTAL CHRONIC TOTAL OCCLUSION (CTO) AND THE COMMON LATERAL PLANTAR. DURING ADVANCEMENT TO THE PT CTO THE 1.25MM PERIPHERAL ROTALINK PLUS COULD NOT ADVANCE TO THE LESION. THE ROTALINK PLUS WAS EXCHANGED FOR ANOTHER SAME SIZE ROTALINK PLUS. THE SECOND 1.25MM PERIPHERAL ROTALINK PLUS ADVANCED TO THE PT CTO. DURING ATHERECTOMY OF THE COMMON LATERAL AND 1.25MM PERIPHERAL ROTALINK PLUS GOT MOMENTARILY STUCK IN THE VESSEL. CONSEQUENTLY, THE PHYSICIAN ADMINISTERED NITROGLYCERIN TO AID IN THE REMOVAL OF THE 1.25MM PERIPHERAL ROTALINK PLUS. ALL THE DEVICES WERE REMOVED INTACT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558747 ↗
• MalfunctionFeb 15, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE WIRE. A 1.25MM PERIPHERAL ROTALINK PLUS AND A PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. AFTER ATHERECTOMY WAS COMPLETED, IT WAS NOTED THAT THE DEVICE ADHERED TO THE ROTAWIRE. THE DEVICES WERE REMOVED THROUGH THE 5FR SHEATH. THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT HAD GOOD RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329977 ↗
• MalfunctionDec 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE THE BROKE. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. UPON LEAVING THE SHEATH, THE DEVICE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10927669 ↗
• MalfunctionNov 3, 2020Output Problem; Intermittent Loss of Power; Output Problem; Intermittent Loss of Power

  IT WAS REPORTED THAT THE DEVICE SPEED EXCEEDS THE SET OPERATIONAL SPEED. VASCULAR ACCESS WAS OBTAINED VIA DORSALIS PEDIS USING A 4F/5F NON-BOSTON SCIENTIFIC DEVICE. THE TARGET LESION WAS LOCATED AT THE RIGHT ANTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, THE BURR WAS ADVANCED INTO THE MID CALF AND FIST PASS WAS ATTEMPTED BUT THE DEVICE STALLED. SUBSEQUENTLY, THE DEVICE WAS BACKED UP USING DYNAGLIDE APPROXIMATELY 2CM AND TRIED AGAIN, AND ONCE AGAIN THE DEVICE STALLED IN THE SAME LOCATION. ANOTHER ATTEMPT WAS MADE BUT THE SAME THING HAPPENED. AT THIS POINT, THE DEVICE WAS REMOVED USING DYNAGLIDE AND PROCEEDED TO COMPLETE THE PROCEDURE USING BALLOON ANGIOPLASTY ONLY. HOWEVER, IT WAS FURTHER NOTED THAT THE MAXIMUM SPEED THE DEVICE REACHED WAS 202,000RPM WHICH EXCEEDS THE SET OPERATIONAL SPEED OF 200,000RPM. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT DID WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778349 ↗
• MalfunctionMar 18, 2020Output Problem; Noise, Audible; Output Problem; Noise, Audible

  IT WAS REPORTED THAT THE DEVICE WENT ABOVE THE SET OPERATIONAL SPEED. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. UPON ABLATION, THE DEVICE WORKED FOR THE FIRST TWO PASSES IN THE VESSEL AND WAS THEN MOVED TO ANOTHER. THE SET OPERATIONAL SPEED WAS 160,000RPM, HOWEVER THE DEVICE WENT ABOVE THE SET OPERATIONAL SPEED AS IT REACHED AT 165,000RPM AT ONE POINT. AN ATTEMPT FOR BURR ROTATION WAS MADE BUT THE PHYSICIAN WOULD LET GO OF THE PEDAL AS IT SOUNDED AS IF AIR WAS COMING FROM THE HANDLE. A SOUND WAS HEARD, AND THE STALL LIGHT LIT UP AS SOON AS THE PHYSICIAN STEPPED ON THE PEDAL. THIS WAS TRIED REPEATEDLY USING THE SAME DEVICE BUT WITH NO SUCCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND EVERYTHING IS FINE WITH THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847524 ↗
• InjuryMar 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROTALINK BURR TIP BROKE. A 1.25MM ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTALINK BURR TIP BROKE AND WAS RETRIEVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9799955 ↗
• MalfunctionOct 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BROKE OFF. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, IMAGING WAS PERFORMED USING AN OPTICROSS 18 BUT THE ULTRASOUND IMAGE WAS LOST AND EVERYTHING WENT BLACK UPON USAGE. IT WAS ALSO REPORTED THAT THE SHAFT OF THE ROTALINK PLUS BROKE OFF. EVERYTHING WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS STOPPED ONCE EVERYTHING WAS OUT OF THE PATIENT. NO COMPLICATIONS REPORTED AND PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261497 ↗
• MalfunctionSep 25, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE ROTAWIRE AND BURR BECAME TWISTED RESULTING IN A ROTAWIRE SEPARATION. 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: No Consequences Or Impact To Patient

  MAUDE report 9119323 ↗
• MalfunctionJul 19, 2019Output Problem; Output Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-JUN-2019. IT WAS REPORTED THAT THE ROTATIONAL SPEED NOT ABLE TO STABILIZE DURING PREPARATION FOR USE. THE 75% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS CATHETER WAS SELECTED FOR USE. DURING PREPARATION OUTSIDE THE PATIENT'S BODY, THE ROTATIONAL SPEED WAS SET TO 180,000 RPM; HOWEVER, IT WAS NOTED THAT THE ROTATIONAL SPEED WENT FROM 150,000 TO 250,000 RPM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS NOTED THAT THE SHEATH WAS TORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808092 ↗
• MalfunctionMay 10, 2019Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THE BURR WAS STUCK ON WIRE. THE TARGET LESION WAS LOCATED IN ANTERIOR TIBIAL ARTERY. A ROTAWIRE AND 1.25MM PERIPHERAL ROTALINK PLUS WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTABLATOR DID NOT ADVANCE TO THE LONGER SEGMENT OF THE ANTERIOR TIBIAL ARTERY. THE PROXIMAL SECTION WAS SUCCESSFULLY TREATED. WHEN THE DEVICE WAS REMOVED, THE BURR WOULD NOT PULL BACK ON THE WIRE AS IT WAS STUCK ON THE WIRE. THE PHYSICIAN ATTEMPTED TO CUT THE CATHETER OFF THE WIRE, HOWEVER IT COULD NOT COME OFF. THE DEVICE WAS REMOVED AS A UNIT AND LOST ACCESS AS A RESULT. ATHERECTOMY OF LOWER EXTREMITIES WAS SUCCESSFUL THOUGH IT COULD NOT ADVANCE FURTHER. A BALLOON WAS PUT DOWN AND THE ARTERY WAS BALLOONED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599600 ↗
• MalfunctionJan 22, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE WIRE BECAME STUCK IN THE DEVICE. A STENOSED TARGET LESION WAS LOCATED AT POSTERIOR TIBIAL ARTERY. A 1.25MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE OVER A ROTAWIRE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE BECAME STUCK IN THE DEVICE. ANOTHER OF THE SAME ROTALINK DEVICE AND A NEW WIRE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269054 ↗