Peripheral RotaLink® Plus M0011402000Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729838920), received between May 30, 2017 and Feb 6, 2026 — classified as 1 death, 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR WAS DETACHED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MODERATELY CALCIFIED POPLITEAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR HIT THE LESION BUT WOULD NOT ADVANCE. UPON REMOVAL OF CATHETER, THE BURR WAS NOT SEEN AND ENDED UP BEING STUCK IN THE HUB OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282629 ↗
• InjuryOct 16, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS DISLODGED AND STUCK IN THE LESION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR TIBIAL ARTERY ATHERECTOMY. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE AND THE DEVICE WERE LODGED IN A CHRONIC OCCLUSION IN THE PERONEAL ARTERY. THE DEVICES COULD NOT BE WITHDRAWN THROUGH THE COMMON FEMORAL ARTERIOTOMY. INTERVENTION INCLUDED EXPOSING THE PERONEAL ARTERY THROUGH THE LOWER LEG TO CUT THE DEVICE FREE AT THE DISTAL END OF THE DEVICE. THE REST OF THE ROTABLATOR WAS REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310492 ↗
• InjuryJul 22, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE ROTABLATOR STOP WORKING. UPON AN ATTEMPT TO REMOVE THE DEVICE, THE TIP GOT DETACHED AND LEFT IN THE LESION. A SNARE WAS USED TO REMOVE THE FRAGMENT AND EXPECTED THE PATIENT FOR A FULL RECOVERY. THE PROCEDURE WAS CANCELLED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795150 ↗
• InjuryDec 8, 2023Detachment of Device or Device Component; Intermittent Loss of Power; Detachment of Device or Device Component; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS DETACHED AND REMOVED WITH A SNARE. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL VESSEL. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED TO TREAT THE ENTIRE LENGTH OF THE VESSEL. THE BURR MADE A STALL SOUND WHEN APPROXIMATELY 2-3 INCHES OF THE VESSEL WAS LEFT TO TREAT. THEN, THE ROTAPRO CATHETER WAS REMOVED BUT IT WAS NOTED THAT THE BURR WAS SHEARED OFF AND REMAINED BEHIND ON THE GUIDEWIRE. SNARES WERE USED TO REMOVE THE DEVICE SUCCESSFULLY AFTER ABOUT 3 HOURS OF EXTRA WORK. AFTER THE DETACHED BURR WAS REMOVED, THE VESSEL WAS REWIRED AND BALLOONED TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295932 ↗
• MalfunctionOct 12, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE ROTALINK BURR WAS STUCK WITH THE ROTAWIRE. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE VERY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND .009 ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE ROTALINK WAS ADVANCED OVER THE ROTAWIRE. HOWEVER, IT WAS NOTED THAT THE ROTAWIRE BECAME STUCK INSIDE THE ROTALINK BURR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17922040 ↗
• MalfunctionJul 31, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER FRACTURE AND FLUID LEAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SIDE OF THE CATHETER AT 1/3 OF THE BACK BEHIND BURR WAS FRACTURED AND CAUGHT UPON INSERTION AFTER IT HAD ALREADY BEEN PRIMED. A LEAK WAS ALSO NOTED SO THE FLUID NEVER MADE IT TO THE TIP OF THE CATHETER. THE PORTION OF THE DEVICE WAS OUTSIDE OF THE BODY AT THE TIME OF FRACTURE. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND 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 17424764 ↗
• InjurySep 30, 2022Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR BROKE OFF AND REMAINED ON THE WIRE, REQUIRING INTERVENTION FOR REMOVAL. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVY CALCIFIED ANTERIOR TIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND ROTAWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INTRODUCED OVER THE WIRE AND IMBEDDED INTO HEAVY CALCIUM. WHILE SPINNING, THE PHYSICIAN PUSHED THE BURR SLIGHTLY, HOWEVER, THE BURR BROKE OFF AND REMAINED ON THE WIRE. THE DETACHED PORTION OF THE DEVICE WAS REMOVED USING A BERN CATHETER. THE WIRE AND CATHETER WERE SLOWLY REMOVED THROUGH THE GROIN SHEATH ALONG WITH THE BURR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509244 ↗
• MalfunctionAug 26, 2022Entrapment of Device; Device Contamination with Chemical or Other Material; Material Integrity Problem; Noise, Audible; Entrapment of Device; Device Contamination with Chemical or Other Material; Material Integrity Problem; Noise, Audible

  IT WAS REPORTED THAT THE BURR WAS STUCK WITH THE ROTAWIRE AND FOREIGN MATTER WAS NOTED ON THE BURR. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND A ROTAWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, A PECKING MOTION WAS USED IN ADVANCING THE BURR; HOWEVER, ON THE SECOND PASS, A CONSTANT BOGGING DOWN NOISE ON THE ADVANCER WAS HEARD AND THE BURR WAS RUNNING VERY SLOW. SUBSEQUENTLY, THE BURR GOT STUCK ON THE WIRE AND COULD NOT BE REMOVED. WHEN THE DEVICE WAS PULLED OUT ALTOGETHER FROM THE PATIENT'S BODY, THEY NOTICED A THIN PLASTIC THAT WAS WRAPPED AROUND THE BURR AND SLIGHTLY AROUND THE SHAFT NEAR THE BURR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15300477 ↗
• MalfunctionJun 15, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE WIRE. A 2.00MM PERIPHERAL ROTALINK PLUS AND A PERIPHERAL ROTAWIRE GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR BECAME STUCK WITH THE WIRE. THE DEVICE WAS REMOVED THROUGH DYNAGLIDE MODE AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14707732 ↗
• MalfunctionMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS NOTED THAT THE BURR CAME OFF WHEN ADVANCING. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN PRESSED THE PEDAL AND STARTED ADVANCING THE BURR, IT WAS NOTED THAT THE BURR CAME OFF. THE DEVICE WAS SLOWLY REMOVED ALL TOGETHER WITH THE WIRE BUT THE BURR DID NOT GET OFF OVER THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860262 ↗
• MalfunctionOct 27, 2021Contamination; Difficult to Remove; Contamination; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE DUE TO FOREIGN MATERIAL. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED POPLITEAL LESION. A ROTALINK PLUS 2.00MM WAS SELECTED FOR TREATMENT. IT WAS NOTED THAT THE ROTALINK PLUS 2.00MM WAS DIFFICULT TO REMOVE. MATERIAL WAS WRAPPED AROUND THE SHAFT OF THE ROTALINK PLUS 2.00MM. THE ROTALINK PLUS 2.00MM WAS REMOVED WITHOUT INTERVENTION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705185 ↗
• MalfunctionMay 18, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER GOT STUCK IN LESION. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE CATHETER GOT STUCK IN LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844793 ↗
• DeathApr 26, 2021Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE ROTABURR WAS STUCK ON THE LESION AND THE ROTAWIRE, WAS REMOVED THROUGH SURGERY AND PATIENT EXPIRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERONEAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS AND A PERIPHERAL ROTAWIRE WERE SELECTED FOR USE AT AN OUTPATIENT FACILITY. DURING PROCEDURE, WITH THE ROTATIONAL SPEED SET AT 180,000RPM, IT WAS NOTED THAT THE BURR STALLED AND BECAME LODGED INTO THE PERONEAL ARTERY. FURTHERMORE, THE BURR COULD NOT BE REMOVED. PHYSICIAN'S COMMENT WAS VASOSPASM PLAYED A ROLE IN THE STUCK BURR. CONSEQUENTLY, THE PATIENT WAS TRANSFERRED VIA AMBULANCE TO THE HOSPITAL AND THE DEVICES WERE REMOVED AS A UNIT THROUGH SURGERY AND THE SURGEON CUT THE DEVICE AT THE PLASTIC HOUSING WITH SCISSORS. THE PROCEDURE WAS CANCELLED/RESCHEDULED AND PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. PATIENT EXPIRED POST SURGERY TO REMOVE THE BURR AND MYOCARDIAL INFARCTION. THE BURR WAS NEVER RECOVERED. THERE WAS NO POSTMORTEM DONE ON THE PATIENT.

  Patient problems: Foreign Body In Patient; Myocardial Infarction; Vasoconstriction

  MAUDE report 11726889 ↗
• MalfunctionNov 20, 2020Entrapment of Device; Intermittent Loss of Power; Entrapment of Device; Intermittent Loss of Power

  IT WAS REPORTED THAT THE BURR WAS UNABLE TO RETRACT OVER THE WIRE. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 2.00MM PERIPHERAL ROTALINK PLUS AND A PERIPHERAL ROTAWIRE WERE SELECTED FOR USE. DURING PROCEDURE, THE BURR STALLED ON TWO OCCASIONS. SUBSEQUENTLY, UPON WITHDRAWAL, IT WAS NOTED THAT THE BURR COULD NOT BE RETRACTED OVER THE ROTAWIRE. THE DEVICES WERE ABLE TO BE REMOVED AS A SINGLE UNIT FROM THE PATIENT'S BODY, BUT LOST WIRE ACCESS WIRE ACROSS THE LESION. A NEW ACCESS WAS OBTAINED AND SUCCESSFUL ANGIOPLASTY WAS PERFORMED TO COMPLETE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10875423 ↗
• MalfunctionApr 14, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR WAS STUCK ON THE WIRE. THE TARGET LESION AREA WAS LOCATED IN THE LEFT POSTERIOR TIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE TOGETHER WITH A ROTAWIRE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR WAS STUCK ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957639 ↗
• MalfunctionApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BURR DETACHED. THE TARGET LESION WAS LOCATED IN THE RIGHT ANTERIOR TIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE IN A RIGHT ANTERIOR TIBIAL ARTERY ATHERECTOMY. DURING PROCEDURE, IT WAS NOTED THAT THE BURR BROKE OFF FROM THE DRIVE SHAFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943085 ↗
• MalfunctionMar 3, 2020Device Contamination with Body Fluid; Material Integrity Problem; Device Contamination with Body Fluid; Material Integrity Problem

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE ROTABURR SHEATH. THE MULTIPLE TIGHT STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND APPROXIMATELY 250MM IN LENGTH OF EXTREMELY HEAVY CALCIFIED SUPERFICIAL FEMORAL AND POPLITEAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR USE. DURING PROCEDURE, AFTER TRANSVERSING ABOUT 100MM OF THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY, IT WAS NOTICED THAT THE DEVICE STOPPED FUNCTIONING CORRECTLY AND BLOOD WAS LEAKING OUT OF THE DEVICE. THE ROTALINK PLUS WAS REMOVED OVER THE ROTAWIRE FROM INSIDE THE PATIENT WITH NO ISSUES OTHER THAN THE DEVICE WAS LEAKING WITH BLOOD/SALINE. THIS WAS AFTER USE OF ABOUT 2-3 MINUTES IN THE PATIENT. IT WAS THOUGHT THAT THE ROTALINK WAS PUNCTURED BY A SHARP CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780975 ↗
• MalfunctionAug 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ROTA BURR DETACHED OFF THE ROTA CATHETER. THE TARGET LESION AREA WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK PLUS WAS SELECTED FOR AN ANGIOGRAM PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE ROTALINK BURR CAME OFF FROM THE ROTA CATHETER AND THE BURR WAS COMPLETELY DISLODGED FROM THE CATHETER WHILE INSIDE THE PATIENT'S BODY. IT WAS CONFIRMED THAT NO COMPONENT OF THE DEVICE WAS LEFT INSIDE THE PATIENT'S BODY. THE ROTAWIRE DISTAL TIP HAS A LARGER DIAMETER SIZE THAN THE ROTABLATOR BURR, SO THE BURR WAS REMOVED UPON REMOVAL OF THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906146 ↗
• MalfunctionJul 17, 2019Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE GUIDEWIRE. THE TARGET LESION WAS LOCATED IN THE TIBIOPERONEAL TRUNK. A 2.00MM PERIPHERAL ROTALINK AND PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE STALLED DURING ADVANCEMENT. ABOUT 75% OF THE ROTABLATION WAS COMPLETED AND THE DEVICE WAS BEING WITHDRAWN IN DYNAGLIDE MODE WHEN THE BURR BECAME STUCK ON THE WIRE. THE PHYSICIAN HAD DIFFICULTY REMOVING IT FROM THE PATIENT'S BODY. THE ROTALINK AND ROTAWIRE WERE REMOVED TOGETHER. THE ROTABLATION PROCEDURE WAS COMPLETED WITH THIS DEVICE AS THE MAJORITY OF THE CASE WAS COMPLETED. THERE WERE MULTIPLE AREAS AND THE LAST AREA WAS WHERE THEY HAD THE PROBLEM. A NEW WIRE WAS ADVANCED AND BALLOONING COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799136 ↗
• MalfunctionJun 3, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE BURR BECAME STUCK WITH THE ROTAWIRE. THE TARGET LESION WAS LOCATED IN POSTERIOR TIBIAL VESSEL. A 2.00MM PERIPHERAL ROTALINK PLUS AND PERPIHERAL ROTAWIRE WERE SELECTED FOR AN ATHERECTOMY PROCEDURE. THE DEVICE WAS USED IN THE UPPER PORTION OF THE POSTERIOR TIBIAL VESSEL. THEN, THE DEVICE WAS ADVANCED TO THE MID POSTERIOR TIBIAL VESSEL AND BECAME ENTRAPPED ON THE WIRE WHILE WHEN ROTATION WAS OCCURRING. SINCE THE DEVICE WAS UNABLE TO BE ADVANCED OR REMOVED FROM THE WIRE, THE ROTALINK AND ROTAWIRE WERE REMOVED TOGETHER AS A UNIT. NO FURTHER ATHERECTOMY WAS COMPLETED AND THE PROCEDURE WAS COMPLETED WITH BALLOONING. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663544 ↗
• InjuryMay 30, 2017Detachment Of Device Component; Detachment Of Device Component

  SAME CASE AS MDR ID: 2134265-2017-05265. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND ROTABURR AND ROTAWIRE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED LEFT INTRATIBIAL ARTERY. A 2.00MM PERIPHERAL ROTALINK® PLUS AND PERIPHERAL ROTAWIRE¿ AND WIRECLIP® TORQUER WERE SELECTED FOR USE. DURING PROCEDURE, MINOR SPEED DROPS WERE NOTED FROM 165,000RPM TO 10,000RPM. WHEN THE PATIENT FELT SOME PAIN, THE DEVICE WAS THEN PROMPTLY REMOVED. FURTHERMORE, IT WAS OBSERVED THAT THE BURR TIP WAS DETACHED FROM THE CATHETER. A UNSPECIFIED BALLOON CATHETER WAS PLACED BEHIND THE DETACHED BURR TIP VIA PEDAL ACCESS AND LONG SHEATH WAS THEN ADVANCED TOWARD THE INTRATIBIAL ARTERY WHERE NEGATIVE PRESSURE WAS APPLIED USING A SYRINGE. THE DETACHED BURR TIP WAS CAPTURED AND WAS REMOVED FROM THE PATIENT'S BODY. MEANWHILE, IT WAS NOTED THAT THE ROTAWIRE BECAME FRACTURED IN THE JUNCTION OF THE INTRATIBIAL ARTERY AND DORSALIS PEDIS ARTERY. THE FRACTURED ROTAWIRE REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A CATHETER BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Pain

  MAUDE report 6597345 ↗