Turnpike® Spiral catheter 5640Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI M20656400), received between Dec 1, 2016 and Mar 31, 2020 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (12 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 18, 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.

• InjuryMar 31, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE TURNPIKE SPIRAL BROKE OFF DURING A PERIPHERAL CASE. THE TURNPIKE SPIRAL WAS BEING USED IN A CTO LESION IN A TORTUOUS 4.0 MM POSTERIOR TIBIAL ARTERY, HOWEVER FURTHER BLOOD FLOW WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO BALLOON THE VESSEL BUT, WAS UNSUCCESSFUL. ONCE THE TURNPIKE SPIRAL WAS STUCK, AN ATTEMPT TO BALLOON OVER THE BROKEN PORTION WAS UNSUCCESSFUL. LATER DURING ATTEMPT,A GUIDEWIRE HAD ALSO FRACTURED OFF INSIDE THE SHEATH BUT WAS ABLE TO BE RETRIEVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9907583 ↗
• MalfunctionJun 17, 2019Unraveled Material; Unraveled Material

  PHYSICIAN PULLED ON THE TURNPIKE SPIRAL, WHEN 2CM OF THE OUTER NYLON COIL WAS SOLIDLY ENTRAPPED IN THE CALCIFICATION, THE NYLON WAS DE-COILED FROM THE CATHETER AND ATTACHED TO THE MICROCATHETER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8704352 ↗
• MalfunctionMay 30, 2019Separation Problem; Separation Problem

  DURING A CTO CASE IN THE RCA THE TIP OF THE TURNPIKE SPIRAL SEPARATED FROM THE CATHETER. RESISTANCE WAS FELT DURING THE PROCEDURE. PHYSICIAN WAS ABLE TO REMOVE THE TIP AND CATHETER. ADDITIONAL INFORMATION RECEIVED 06MAY19: THE TIP WAS STUCK ON THE WIRE, SO THE CATHETER AND WIRE WERE REMOVED TOGETHER. NO MEDICAL INTERVENTION WAS REPORTED. OUTCOME OF PATIENT IS REPORTED AS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655411 ↗
• MalfunctionJan 25, 2019Separation Problem; Separation Problem

  PHYSICIAN HAD A SEPARATION OF THE ENTIRE TIP OF THE CATHETER. ADDITIONAL INFORMATION RECEIVED 15JAN19: THE TIP WAS IRRETRIEVABLE. THE PHYSICIAN WAS PERFORMING AN INTERVENTION TO TRY AND OPEN THE PATIENTS 1ST DIAGONAL BRANCH (UNSUCCESSFULLY). THE PHYSICIAN STATED THEY WERE RUNNING A TURNPIKE SPIRAL OVER A WIRE. THERE IS NO FOLLOW-UP PROCEDURE PLANNED. THE PATIENT IS REPORTED AS STABLE AND THERE WERE NO NEGATIVE COMPLICATIONS SECONDARY TO THIS EVENT. NO IMPACT TO PATIENT REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8278756 ↗
• MalfunctionJan 9, 2019Separation Problem; Separation Problem

  THE PHYSICIAN REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION AND WHEN HE REMOVED THE DEVICE NOTED THAT THE TIP WAS DAMAGED AND A LITTLE PART OF IT REMAINED STUCK IN THE LESION. ADDITIONAL INFO REC'D (B)(6) 2018: THE PHYSICIAN REPORTED THAT HE ENCOUNTERED RESISTANCE IN ADVANCING THE TURNPIKE SPIRAL BECAUSE THE PROXIMAL CAP OF THE LESION WAS HARD TO CROSS; NO RESISTANCE IN ADVANCING THE MICROCATHETER ON THE GUIDEWIRE UNTIL THE PROXIMAL CAP OF THE LESION. THE PHYSICIAN USED A GUIDE CATHETER EXTENSION (GUIDELINER) AND TWO DIFFERENT GUIDEWIRES. THE PHYSICIAN DID NOT TRY TO REMOVE THE "LITTLE PART" FROM THE LESION. THE PROCEDURE WAS NOT COMPLETED BECAUSE IT WAS NOT POSSIBLE TO CROSS THE LESION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8232609 ↗
• InjuryOct 9, 2018Separation Problem; Separation Problem

  PHYSICIAN WAS PERFORMING A PCI ANGIOPLASTY AND ATHERECTOMY ON A CALCIFIED LESION IN THE LEFT DISTAL CIRCUMFLEX. HE WAS ATTEMPTING TO ROTATE OUR TURNPIKE SPIRAL THROUGH A TIGHT DISTAL LESION WHEN THE TIP OF THE CATHETER BROKE OFF AND WAS LODGED INTO THE LESION. THE IDEA WAS TO CROSS WITH THE TURNPIKE SPIRAL AND TO SWITCH OUT FOR THE FLOPPY ROTOWIRE TO ATHERECTOMY THE PLAQUE. AFTER THE TIP WAS LODGED THEY ABORTED THE ATHERECTOMY AND PERFORMED AN ANGIOPLASTY. THE TIP REMAINS IN THE PATIENTS DISTAL LEFT CIRC. AND IS RESTING IN STABLE CONDITION IN THE ICU. THE REASON THE PATIENT WAS TRANSFERRED TO THE UNIT WAS FOR OBSERVATION TO MAKE CERTAIN THE FOREIGN BODY DIDN'T MIGRATE AND THE PATIENT WOULD BLEED AND BECOME UNSTABLE. IT IS REPORTED THAT THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7949151 ↗
• MalfunctionSep 7, 2018Separation Problem; Separation Problem

  PHYSICIAN NOTICED WHAT LOOKED LIKE TIP SEPARATION WITH TURNPIKE SPIRAL. HE HAD BEEN TORQUING TS IN OM BOTH CLOCKWISE AND COUNTERCLOCKWISE. WHEN HE SAW WHAT LOOKED LIKE TIP SEPARATION HE REMOVED WIRE AND CATHETER TOGETHER FINDING TURNPIKE SPIRAL TO BE INTACT BUT TIP WAS ALMOST SEPARATED HANGING BY FRAYED MATERIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855215 ↗
• InjuryJul 11, 2018Use of Device Problem; Separation Problem; Use of Device Problem; Separation Problem

  IN A VERY TORTUOUS RCA LESION, THE DOCTOR USED TURNPIKE SPIRAL. AFTER BEING ADVANCED AROUND 3 MM, IT COULD NO LONGER BE ADVANCED; THE DOCTOR RE-TREATED THE TURNPIKE A BIT AND TRIED TO ADVANCE AGAIN, BUT STILL COULD NOT ADVANCE IT. FINALLY THE DOCTOR WITHDREW THE TURNPIKE AND FOUND THE OUTER COIL HAS BEEN COME OFF FROM THE CATHETER. ADDITIONAL INFORMATION RECEIVED 02JUL18. PATIENT DATA IS CONFIDENTIAL. THE CATHETER WAS REMOVED AND THE USER FOUND THE COIL CAME OFF BUT STILL VISIBLE ON THE CATHETER. THE USER SAID THERE WAS NO ADDITIONAL TORQUING. THE TIP CAUGHT IN THE OCCLUSION OF THE LESION SECTION. NO FURTHER RETRIEVE DEVICE WAS USED FOR THE COIL. THE PATIENT WAS SENT TO SURGERY AT A LATER TIME, THE PHYSICIAN FOUND A GUIDEWIRE WAS BROKEN (NOT RELATED TO THE USE OF TURNPIKE) IN THE VESSEL AND IT WAS UNABLE TO KEEP DOING THE INTERVENTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7678562 ↗
• InjuryMay 1, 2018Detachment Of Device Component; Detachment Of Device Component

  PHYSICIANS WERE WORKING ON AN OM2 FOLLOWING A WIRE. GOT PAST THE LESION WITH THE WIRE, AND THE TURNPIKE SPIRAL. UPON TRYING TO REMOVE THE TURNPIKE SPIRAL, THEY NOTICED THE TIP SEPARATED. IT EMBOLIZED AND ALL EFFORTS TO RETRIEVE THE TIP WERE NOT SUCCESSFUL. THEY ATTEMPTED TO LASER THE LESION AFTER THIS ATTEMPT FAILED. THE PATIENT WAS THEN TRANSPORTED TO THE OR TO HAVE A 4 VESSEL CABG PERFORMED. TODAY THE PATIENT IS DOING OK. INFORMATION RECEIVED FROM MEDWATCH (IDENTIFIER # NOT PROVIDED): DURING CARDIAC CATH PROCEDURE, A TURNPIKE SPIRAL CATHETER WAS USED IN AN ATTEMPT TO CROSS A LESION IN THE OM2 ARTERY. CATHETER WOULD NOT PASS AND WAS NOTED TO BE TORQUED IN THE LESION CAUSING THE TIP TO SHEAR OFF AND EMBOLIZED IN THE VESSEL. WHEN ATTEMPTING TO EXCHANGE THE WIRE WITH A TURNPIKE LP WIRE, THE EMBOLIZED TIP BECAME LODGED AND OCCLUDED BLOOD FLOW.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7476590 ↗
• MalfunctionApr 18, 2018Detachment Of Device Component; Detachment Of Device Component

  DOCTOR WAS UNSUCCESSFUL IN RESOLVING THIS CTO AND WILL BE ATTEMPTING AGAIN IN TWO MONTHS TIME. COULD NOT PROGRESS THROUGH A RETROGRADE APPROACH AND THEN PROCEEDED WITH AN ANTEGRADE APPROACH. COULD NOT PENETRATE THE PROXIMAL CAP. THE TURNPIKE GOLD WAS BENT AT A 45 DEGREE ANGLE WITH A WIRE STUCK IN IT. THE WIRE AND TURNPIKE HAD TO BE REMOVED THROUGH THE SHEATH TOGETHER. DR. WAS ATTEMPTING TO NAVIGATE THROUGH THE PROXIMAL CAP OF A MID. CIRC. LESION, 9 DIFFERENT WIRES WERE USED, AND 5 VARIOUS TURNPIKES WERE ALSO USED. THE TIPS OF THE LP AND SPIRAL CATHETERS WERE DEFORMED AND HAD DIFFICULTY REMOVING THE WIRE. THIS REPORT IS ASSOCIATED TO MEDWATCH 2134812-2018-00022.

  Patient problems: No Information

  MAUDE report 7441084 ↗
• MalfunctionApr 18, 2018Detachment Of Device Component; Detachment Of Device Component

  DOCTOR WAS UNSUCCESSFUL IN RESOLVING THIS CTO AND WILL BE ATTEMPTING AGAIN IN TWO MONTHS TIME. COULD NOT PROGRESS THROUGH A RETROGRADE APPROACH AND THEN PROCEEDED WITH AN ANTEGRADE APPROACH. COULD NOT PENETRATE THE PROXIMAL CAP. THE TURNPIKE GOLD WAS BENT AT A 45 DEGREE ANGLE WITH A WIRE STUCK IN IT. THE WIRE AND TURNPIKE HAD TO BE REMOVED THROUGH THE SHEATH TOGETHER. DR. WAS ATTEMPTING TO NAVIGATE THROUGH THE PROXIMAL CAP OF A MID. CIRC. LESION, 9 DIFFERENT WIRES WERE USED, AND 5 VARIOUS TURNPIKES WERE ALSO USED. THE TIPS OF THE LP AND SPIRAL CATHETERS WERE DEFORMED AND HAD DIFFICULTY REMOVING THE WIRE. THIS REPORT IS ASSOCIATED TO MEDWATCH 2134812-2018-00023.

  Patient problems: No Information

  MAUDE report 7441028 ↗
• InjuryMar 23, 2018Detachment Of Device Component; Detachment Of Device Component

  DURING A PTCA PROCEDURE, AFTER AN UNSUCCESSFUL ATTEMPT OF USE OF THE TURNPIKE SPIRAL CATHETER, IT WAS RETRIEVED OUT FROM PATIENT. HOWEVER, DR. FOUND THAT THE TIP OF THE TURNPIKE SPIRAL CATHETER WAS DAMAGED AND A LITTLE PART OF THE RADIOPAQUE TIP WAS MISSING FROM THE CATHETER AND LEFT IN PATIENT BODY. THE PROCEDURE WAS THEN COMPLETED WITH OTHER CATHETERS. THE PATIENT WAS MONITORED AFTER THE PROCEDURE AND THEN WAS DISCHARGED WITHOUT ANY ADVERSE EVENT. REPORTED AS NO IMPACT TO PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 7367234 ↗
• InjuryMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  DR. HAD A VERY CALCIFIED TORTUROUS RCA. THE WIRE WENT DOWN FINE AND ONCE HE STARTED TO DELIVER THE TP HE SAID IT WAS ADVANCING NO PROBLEM. ONCE HE SAW HE WAS IN THE TORTUOUS VESSEL IT STOPPED TRACKING AND NOTHING HE DID WOULD RELEASE IT. THE TIP ALSO APPEARED OFF THE CATHETER. HE EVENTUALLY PUT A 3MM STENT WITH A SECOND WIRE AND THEN PULLED EVERYTHING OUT WITH GREAT EFFORT. THE TIP WAS NOT ATTACHED TO THE CATHETER. I BELIEVE IT WAS SEPARATED BUT PULLED OUT WITH THE WIRE. DR. THEN WAS ABLE TO FINISH THE CASE WITH ADDITIONAL STENT AND BALLOON.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7359709 ↗
• InjuryFeb 27, 2018Detachment Of Device Component; Detachment Of Device Component

  SPIRAL PORTION OF CATHETER BROKE OFF IN CORONARY ARTERY. RETROGRADE ACCESS OBTAINED AND REVERSE CART DONE AND STENTS DEPLOYED TO EMBED SPIRAL IN ARTERIAL WALL. AS UNABLE TO RETRIEVE IT AFTER MULTIPLE ATTEMPTS. AS REPORTED: "THE PATIENT IS FINE. THE PIECE OF NYLON WAS LEFT BEHIND IN THE ARTERY AND STENTED OVER TO PREVENT IT FROM MOVING." UNFORTUNATELY UNABLE TO GIVE SPECIFIC INFORMATION ABOUT THE PATIENT DUE TO THE (B)(4) PRIVACY LAWS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7300837 ↗
• MalfunctionOct 26, 2017Detachment Of Device Component; Detachment Of Device Component

  TIP FRACTURED AND BECAME EMBEDDED IN THE ARTERY. NO PATIENT IMPACT REPORTED.

  Patient problems: No Information

  MAUDE report 6979128 ↗
• MalfunctionOct 19, 2017Detachment Of Device Component; Detachment Of Device Component

  THE TIP BROKE OFF IN A VESSEL. NO FURTHER INFORMATION WILL BE SUPPLIED PER SITE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963000 ↗
• MalfunctionFeb 9, 2017Device Or Device Fragments Location Unknown; Device Dislodged or Dislocated; Device Or Device Fragments Location Unknown; Device Dislodged or Dislocated

  THE SUPPLY MANAGER REPORTED THAT THE TIP OF THE TURNPIKE SPIRAL CAME OFF ON THE GUIDEWIRE. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6313766 ↗
• MalfunctionJan 16, 2017Detachment Of Device Component; Detachment Of Device Component

  A TURNPIKE SPIRAL WAS INSERTED INTO A CALCIFIED VESSEL. THE TURNPIKE SPIRAL'S TIP LOCKED UP ON THE WIRE AND THE TIP CAME OFF IN THE PATIENT ON THE WIRE. THE TIP WAS STUCK TO THE WIRE; TIP AND GUIDEWIRE REMOVED IN TANDEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6254379 ↗
• MalfunctionJan 12, 2017Detachment Of Device Component; Detachment Of Device Component

  TIP BROKE FROM THE TURNPIKE SPIRAL, HOWEVER, IT STUCK OVER THE GUIDEWIRE. THEY MANAGED TO GET IT OUT FROM THE PATIENT; WITH THE GUIDEWIRE TOGETHER, THE LOOSE PART WAS STUCK ON THE GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6247990 ↗
• MalfunctionJan 6, 2017Detachment Of Device Component; Difficult to Advance; Detachment Of Device Component; Difficult to Advance

  WHEN TRYING TO ADVANCE A TURNPIKE SPIRAL THROUGH A VERY CALCIFIED LESION, THE TIP BROKE OFF, AND GOT STUCK IN THE LESION ON THE WIRE. THE RESULT WAS THAT NOTHING COULD PASS OVER THE WIRE. THEY COULD NOT ADVANCE ANYTHING OVER A PARALLEL WIRE. THIS COULD OF COURSE WAS DUE TO THE LESION ITSELF, BUT THE BROKEN TIP DID NOT MAKE IT EASIER. THE WIRE ITSELF WAS STUCK BECAUSE THE RUBBER FROM THE TIP CAUSED IT TO BE JAMMED IN THE LESION. WE MANAGED TO PULL IT OUT, PUT USING CONSIDERABLE FORCE. THE CASE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6229020 ↗
• InjuryDec 1, 2016Detachment Of Device Component; Material Separation; Device Contamination with Chemical or Other Material

  AFTER REMOVAL OF THE TURNPIKE SPIRAL FROM THE PATIENT, THE TIP WAS SEPARATED OFF THE CATHETER AND STUCK ON THE WIRE. THE TURNPIKE SPIRAL DID ITS JOB IN CROSSING A TIGHT TORTUOUS DIAGONAL FROM A VEIN GRAFT. IT HAD TO MAKE A 180 DEGREE TURN AT THE ANASTOMOSIS AND THEN ADVANCE RETROGRADE UP THE DIAGONAL TO CROSS THE LESION. WIRE AND TURNPIKE SPIRAL POSITION WAS LOST, PROBABLY DUE TO LACK OF SUPPORT WITH THE GUIDE THEY USED. THEN PHYSICIAN PULLED EVERYTHING OUT AND STARTED OVER WITHOUT HAVING TO INTERVENE TO GET THE TURNPIKE OUT. WHEN THEY LOOKED AT THE WIRE, THEY NOTICED A SMALL BLACK PIECE ABOUT AN INCH IN FRONT OF THE TURNPIKE SPIRAL ITSELF. IT DID NOT STAY IN THE PATIENT. NO OTHER DEVICE WAS USED AFTER THE TURNPIKE SPIRAL BECAUSE AFTER LOSS OF POSITION, PHYSICIAN WAS ABLE TO RE-WIRE THE LESION BUT CREATED A DISSECTION SO THE CASE WAS ABANDONED. THE PATIENT DID FINE WITH NO EVENTS AND WENT HOME THAT AFTERNOON.

  Patient problems: Vascular Dissection

  MAUDE report 6137748 ↗