Turnpike® LP catheter 5638Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI M20656380), received between Jan 11, 2017 and Jan 14, 2022 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2022Material Separation; Material Separation

  AS REPORTED: THE MICROCATHETER WAS USED TO SUPPORT WIRING OF TOTALLY OCCLUDED RCA, BUT IT WAS BROKEN EASILY DESPITE GENTLE USE AND HANDLING". THE MICROCATHETER WAS INTRODUCED UNTIL A CERTAIN POINT AND NO MORE ADVANCEMENT WAS DONE AND IT BROKE, THE WHOLE DEVICE WAS REMOVED WITHOUT ANY SEPARATION. REPORTED THAT NO CONSEQUENCES WERE CAUSED BY THE DEVICE PROBLEM AND NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261708 ↗
• InjuryApr 16, 2019Separation Problem; Separation Problem

  MW5084730 RECEIVED 21MAR2019. NO INITIAL REPORTER INFORMATION WAS DOCUMENTED ON THE MEDWATCH RECEIVED. THE TURNPIKE LP CATHETER WAS BEING USED FOR PCI IN A SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY LESION. THE TIP OF THE CATHETER BROKE OFF FROM THE CATHETER. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO ASPIRATE OUT THE FRAGMENT. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR URGENT CORONARY ARTERY BYPASS GRAFTING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8520567 ↗
• MalfunctionMar 7, 2019Separation Problem; Separation Problem

  PHYSICIAN WAS UTILIZING A TURNPIKE LP IN A HEAVILY CALCIFIED RCA. AS HE WAS SPINNING THE TURNPIKE LP, HE FELT IT CATCH AND IT WOULD NO LONGER SPIN. HE SPUN IT THE OPPOSITE DIRECTION TO FREE IT AND UPON REMOVAL NOTICED A "FRACTURE" IN THE TIP. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ON HOW THE TIP WAS RETRIEVED HOWEVER, NO REPLY HAS BEEN RECEIVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8401193 ↗
• InjuryAug 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS TRYING TO CROSS A HEAVILY CALCIFIED LESION, AND REPORTS THAT THE TIP OF THE CATHETER BROKE OFF. PLANNED STRATEGY WAS TO FIX LAD LESION THEN DO A TAVR. DUE TO THIS INCIDENT PATIENT'S TAVR (TRANSCATHETER AORTIC VALVE REPLACEMENT) PROCEDURE WAS DONE THE SAME DAY. DURING THE PROCEDURE IT WAS NOTED THE TIP HAD MIGRATED INTO A SEPTAL BRANCH WHERE IT WAS SPECULATED IT WOULD NOT HARM THE PATIENT. IT WAS NOTED THE TIP MIGRATED TO A SEPTAL BRANCH AND NO FURTHER INTERVENTION WOULD BE REQUIRED. PATIENT WAS BEING DISCHARGED TO HOME ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7832365 ↗
• InjuryAug 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  AS THE CARDIOLOGIST WAS DOING THE PROCEDURE HE CAME ACROSS SEVERE CALCIFICATION PRESENT WITH BIFURCATION AND ATTEMPTED TO PASS WITH SEVERAL BALLOONS AFTER USING A GUIDE AND CROSSING THE LESION WITH A LUGE WIRE VIA THE RADIAL ARTERY, CARDIOLOGIST OBTAINED ACCESS OF THE RIGHT FEMORAL ARTERY AND ABLE TO RE-WIRE WITH 8 FRENCH GUIDE, THE TURNPIKE LP THEN FRACTURED AND PLUGGED THE VESSEL RESULTING IN CESSATION OF FLOW AND COULD NOT REMOVE THE WIRE AS IT WAS FIXED AND ONCE THAT WAS CLEAR DID NOT WANT TO LOSE WIRE POSITION. ST SEGMENTS ELEVATED AND THEN ABLE TO PASS 1.2 MM BALLOON THROUGH THE LESION AND IT PUSHED THE TIP OF THE CATHETER DOWNSTREAM, BALLOON INFLATED AND THE TURNPIKE WAS ADVANCED AND THE ROTA WIRE WAS EXCHANGED. PT DID RECEIVE STENTS. THE PATIENT IS REPORTED AS DOING FINE. PATIENT DISCHARGED TO HOME (B)(6) 2018. INITIAL INFORMATION RECEIVED VIA MEDWATCH 5078186 ON JULY 09, 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7761803 ↗
• MalfunctionJul 5, 2018Detachment Of Device Component; Detachment Of Device Component

  PHYSICIAN WAS USING TURNPIKE IN A SUB-TOTAL OCCLUSION, TRYING TO EXCHANGE THE WIGGLE WIRE FOR A ROTOWIRE. HE TURNED THE CATHETER INTO THE LAD. THERE WAS CALCIUM PRESENT, BUT NOT A FULL CTO. THE TURNPIKE TIGHTENED DOWN ON THE WIGGLE WIRE AND PART OF THE TIP BROKE OFF AND STAYED ON THE WIGGLE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7663780 ↗
• InjuryMar 5, 2018Detachment Of Device Component; Detachment Of Device Component

  PHYSICIAN WAS USING TURNPIKE TO ASSIST IN WIRING THE OBTUSE MARGINAL VESSEL. WHILE ATTEMPTING THIS MULTIPLE TIMES THE TIP OF THE TURNPIKE LP BROKE OFF INSIDE THE VESSEL. PHYSICIAN ATTEMPTED TO WIRE THE VESSEL AFTER THIS HAPPENED SO AS TO RETRIEVE THE TIP, BUT W/O SUCCESS. HE WAS QUOTED BY THE STAFF AS SAYING "HE DIDN'T NEED TO RETRIEVE THE TIP BECAUSE THE VESSEL WAS SHUT DOWN AND IT WOULDN'T MIGRATE ANY FURTHER". THE PATIENT WAS ALERT AND ORIENTED AFTER DEPARTING THE CATH LAB AND NO ISSUES SINCE. NO PATIENT IMPACT OR INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7313433 ↗
• InjuryJan 9, 2018Detachment Of Device Component; Detachment Of Device Component

  THE TIP OF THE TURNPIKE BROKE DOWN IN THE CORONARY WHILE ADVANCING. THE TIP WAS REMOVED SUCCESSFULLY WITH LASSO CATHETER. DELAY OF PROCEDURE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176220 ↗
• MalfunctionJan 9, 2018Detachment Of Device Component; Detachment Of Device Component

  MD NOTICED THAT THE TIP OF DEVICE SEPARATED FROM SHAFT, THE TIP DISLODGED, HOWEVER, WAS INTACT ON THE WIRE. MD REMOVED THE ENTIRE SYSTEM WITHOUT INCIDENT OR HARM TO THE PATIENT. PROCEDURE RESUMED WITHOUT EVENT. NO HARM TO PATIENT. ALL OF THE DEVICE RETRIEVED. ADDITIONAL INFORMATION RECEIVED, THE DEVICE WILL NOT RETURN FOR INVESTIGATION. RECEIVED INFORMATION ON (B)(6) 2017, ON MEDSUN MANDATORY AND VOLUNTARY REPORT FORM UF/IMPORTER # (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176065 ↗
• InjuryNov 30, 2017Detachment Of Device Component; Detachment Of Device Component

  PHYSICIAN WAS USING THE TURNPIKE LP FOR A CTO. HE FELT THE TIP BECAME LODGED IN AN AREA OF CALCIUM AND THE TIP DISLODGED. THE TIP WAS NOT ABLE TO BE RETRIEVED. ADDITIONAL INFORMATION RECEIVED VIA MEDSUN UF IMPORTER REPORT# (B)(4): THE PATIENT HAS VERY CALCIFIED ARTERIES AND THE CATHETER TIP TORE IN THE CALCIUM. THE TIP EMBOLIZED DOWN AND COULD NOT BE RETRIEVED DUE TO DISTAL LOCATION. THE CORONARY ARTERY HAD NORMAL FLOW AT THE END OF THE CASE. OTHER INFORMATION RECEIVED ABOUT THE PATIENT: THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: ON (B)(6) 2016 LHC TO FIX LEFT CIRCUMFLEX BUT FAILED WITH EMBOLIZATION OF BALLOON TIP TO DISTAL LCX. ON (B)(6) 2017 PATIENT WENT FOR STAGED PCI OF THE LEFT CX LASER ATHERECTOMY AND DURING THE PROCEDURE HAD FRACTURE OF THE ANGIOPLASTY BALLOON WHICH EMBOLIZED DISTAL LEFT CX AND WAS UNABLE TO RETRIEVE AFTER MULTIPLE ATTEMPTS.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7072011 ↗
• MalfunctionNov 15, 2017Detachment Of Device Component; Detachment Of Device Component

  MD REPORTED USING THE TURNPIKE LP FOR MEDICINE SYRINGE INJECTIONS DURING A CORONARY CASE. AFTER THE THIRD INJECTION, THE HUB OF THE TURNPIKE LP BROKE OFF. MD REPORTED NOT USING EXCESS FORCE WITH HAND INJECTIONS. MD REPORTED THAT NO PRODUCT WAS LEFT IN PATIENT, AND NO COMPLICATIONS TO PATIENT CARE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7034660 ↗
• InjuryAug 30, 2017Detachment Of Device Component; Detachment Of Device Component

  PATIENT UNDERWENT PCI OF MID -LAD, WHERE A HAEMODYNAMICALLY SIGNIFICANT STENOSIS WAS FOUND (FFR BELOW 0,75). ONLY ONE 2.0 MM BALLOON WAS DILATED, BUT AFTER THIS NO OTHER BALLOON COULD CROSS THE LESION. IN ORDER TO CHANGE TO ROTAWIRE A TURNPIKE LP WAS ATTEMPTED TO GET THROUGH THE LESION. NO EXCESSIVE TORQUEING WAS USED, BUT THE TIP GOT STUCK TO THE LESION AND A VERY SMALL PART OF IT CAME OFF. WITH TURNPIKE GOLD THE LESION WAS CROSSED AND DILATED AFTERWARDS. THE TIP KEPT ON EMBOLIZING FURTHER AND DESPITE DIFFERENT APPROACHES COULD NOT BE RETRIEVED BUT EMBOLIZED TO A VERY SMALL AND DISTAL BRANCH WITHOUT OBVIOUS LOSS WORSENING OF BLOOD FLOW. PATIENT WAS VERY SYMPTOMATIC AFTERWARDS, BUT NO ECG CHANGES WERE PRESENT. HOWEVER, TNT ROSE FROM IMMEDIATE 30 NG/L TO 480 NM/L, DESPITE WHICH PATIENT INSISTED ON BEING DISCHARGED. EVENTUALLY, PATIENT UNDERWENT APPROXIMATELY TWO WEEKS LATER PCI OF LCX DUE TO CONTINUING SYMPTOMS. EVEN THIS HAS NOT RESOLVED PATIENTS SYMPTOMS. PATIENT OUTCOME RESOLVED WITH POSSIBLE SEQUELAE (NSTEMI EVIDENT) - PATIENT IS SYMPTOMATIC, BUT IT IS DIFFICULT TO DETERMINE THE CAUSALITY BETWEEN THE EVENT AND SYMPTOMS DUE TO THEIR VAGUE NATURE.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6831444 ↗
• MalfunctionMay 31, 2017Detachment Of Device Component; Detachment Of Device Component

  CTO OF HEAVILY CALCIFIED RCA LESION. THIS WAS A VERY DIFFICULT LESION AND MULTIPLE ATTEMPTS WERE MADE TO CROSS WITH THE TURNPIKE LP AND SPIRAL. DURING THE PROCEDURE IT WAS NOTICED THAT THE TIP OF THE TURNPIKE LP HAD SEPARATED AND WAS STILL ATTACHED TO THE WIRE. THE WIRE AND CATHETER WAS REMOVED AND TAKEN OFF THE FIELD. THE MD STATED THAT HE WAS NOT SURPRISED DUE TO THE MANIPULATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6602177 ↗
• MalfunctionFeb 8, 2017Device Or Device Fragments Location Unknown; Device Dislodged or Dislocated; Device Or Device Fragments Location Unknown; Device Dislodged or Dislocated

  PHYSICIAN WAS USING TURNPIKE LP FOR A LAD ANTEGRADE CTO CASE. THE LP WOULD NOT ADVANCE PAST THE LESION, WHEN PHYSICIAN PULLED OUT THE TURNPIKE LP, THE TIP OF THE CATHETER HAS SHEARED OFF. TURNPIKE WAS REMOVED WITH WIRE. ADDITIONAL INFORMATION RECEIVED 29NOV2016: NOTHING WAS LEFT IN THE BODY, AND NO RETRIEVAL METHOD WAS NECESSARY. NO PATIENT INJURY OR IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6311752 ↗
• InjuryJan 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  TURNPIKE LP TIP FRACTURED AND WAS STUCK IN RIGHT CORONARY ARTERY AFTER 3RD ATTEMPT TO NAVIGATE THROUGH TORTUOUS AND CALCIFIED ANATOMY. TIP WAS NOT RETRIEVED, THE TIP WAS LEFT IN THE PATIENT. PATIENT WAS HAVING AN AMI. NO PATIENT IMPACT REPORTED; MEDICATION WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6243407 ↗