Turnpike Spiral catheterRecalls & reported problems across all models

We found 2 models of Turnpike Spiral catheter by Vascular Solutions, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2016 and Mar 31, 2020 — classified as 8 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Turnpike Spiral catheter problems

Turnpike Spiral catheter models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Turnpike® Spiral catheter 5640

  Catheter, Percutaneous
  21 reports
• Turnpike® Spiral catheter 5641

  Catheter, Percutaneous
  2 reports

Recent Turnpike Spiral catheter adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 23, 2018Detachment Of Device Component; Detachment Of Device Component

  TURNPIKE SPIRAL WAS DAMAGED. THE INFORMATION REPORTED WAS THE "WIRE CAME OFF THE TIP OF THE CATHETER IN THE VESSEL" . IT IS REPORTED THAT THE TIP WAS NOT RETRIEVED AND NOT ON THE WIRE. IT WAS REPORTED AS NO IMPACT OR INJURY TO PATIENT. THE PATIENT WAS STABLE LEAVING THE LAB.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7366991 ↗
• 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 ↗

Other Vascular Solutions, Inc. products

• Turnpike LP catheter2 models · 34 reports