Turnpike® LP catheter 5639Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI M20656390), received between Dec 21, 2016 and Jan 16, 2019 — classified as 1 death, 9 injuries, 9 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, 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2019Separation Problem; Separation Problem

  DURING A CTO CASE THE HUB CRACKED OFF THE CATHETER. THE TURNPIKE CATHETER WAS USED IN A CTO CASE AND AFTER SOME TIME, THE HUB FATIGUED AND CRACKED OFF THE CATHETER. HAD TO RETRACT IT OUT OF THE BODY AND SWITCHED TO A DIFFERENT CATHETER. NO ADVERSE PATIENT OUTCOMES OR IMPACT WERE NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252577 ↗
• MalfunctionJan 16, 2019Separation Problem; Separation Problem

  PHYSICIAN WAS DOING A RETROGRADE CTO CASE. THE PROXIMAL HUB/TORQUE BOOT BROKE OFF FROM MAIN BODY OF CATHETER. HE WAS ABLE TO REMOVE THE TURNPIKE LP CATHETER FROM THE WIRE AND USED ANOTHER TURNPIKE LP DURING CASE. PHYSICIAN REPORTED HE WAS MEETING A LOT OF RESISTANCE WHILE TORQUEING THE TURNPIKE LP BUT DIDN'T PULL BACK ON CATHETER TO RELIEVE THE TORQUE BUILD UP OR REVERSE THE DIRECTION OF TORQUEING. NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252511 ↗
• MalfunctionJan 16, 2019Separation Problem; Separation Problem

  TURNPIKE LP WAS DEEPLY ADVANCED IN HEAVILY CALCIFIED VESSEL, AND WITH CONTINUED TORQUEING THE HUB SEPARATED AND CAME OFF THE CATHETER. NO PATIENT INJURY OR IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252359 ↗
• InjuryNov 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN HAD A VERY DIFFICULT RETROGRADE CTO CASE AND USED THE TURNPIKE LP 150 TO ACCESS THE COLLATERAL BRANCHES. WHILE SPINNING THE CATHETER IN BOTH DIRECTIONS, THE HUB OF THE TURNPIKE LP 150 BROKE OFF. SPENT AN HOUR AN A HALF WORKING ON GETTING THE CATHETER OUT WITH OUT LOSING THEIR WIRE PLACEMENT. THE CATHETER CAME OUT, HOWEVER, NOT IN ONE PIECE. PHYSICIAN HAD TO CUT IT TO REMOVE CATHETER W/O LOSING WIRE.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8080198 ↗
• InjuryNov 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A PILOT 200 WIRE WAS USED WITH THE TURNPIKE LP, WHEN THE WIRE WAS REMOVED THROUGH THE TURNPIKE LP IT WAS SHREDDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: AFTER SEVERAL ATTEMPTS THE TURNPIKE LP DID NOT PASS THE LESION, AND THEN IT GOT STUCK IN THE LESION. THE WIRE INSIDE THE TURNPIKE LP WAS ALSO STUCK. PHYSICIAN HAD TO TUG HARD ON THEM BOTH AND THEY BOTH FINALLY CAME OUT TOGETHER. PHYSICIAN NOTICED THE TIP OF THE WIRE WAS SHREDDED, (THE WIRE WAS SHREDDED/UNRAVELED. NO PARTS SEPARATED COMPLETELY) PART OF THE TURNPIKE LP TIP ADHERED ON TO THE WIRE. NO FRAGMENTS WERE LEFT IN THE PATIENT. AFTER REMOVING THE WIRE AND TURNPIKE LP, PHYSICIAN SAID THE LAD AND CIRCUMFLEX ARTERIES 'SHUT DOWN'. THIS RESULTED IN PATIENT CHEST PAIN AND BUMP OF TROPONIN LEVELS IN THE PATIENT. EVENTUALLY PHYSICIAN WAS ABLE TO STABILIZE THE PATIENT WHO IS DOING FINE.

  Patient problems: Chest Pain

  MAUDE report 8037608 ↗
• MalfunctionJun 14, 2018Detachment Of Device Component; Detachment Of Device Component

  HUB OF THE TURNPIKE LP SEPARATED FROM CATHETER DURING TORQUING. PATIENT WAS UNHARMED AS WIRE AND CATHETER WERE REMOVED AND PROCEDURE WAS RESTARTED. A DIFFERENT CATHETER WAS UTILIZED WITHOUT INCIDENT IN WAKE OF SEPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600807 ↗
• InjuryApr 27, 2018Detachment Of Device Component; Detachment Of Device Component

  LAD WAS WIRED ANTEGRADE ON THE SUPPORT OF A MICRO-CATHETER, PHYSICIAN BALLOONED AND STENTED THE VESSEL FROM MID TO PROXIMAL, IN ORDER TO PERFORMED POST DILATION . PHYSICIAN NEEDED TO REINSERT THE MICRO-CATHETER TO EXCHANGE THE WIRE. THE TIP OF THE TURNPIKE GOT DISLODGED, AND STUCK IN THE MID LAD AND SUBSTANTIAL EFFORTS WERE NEEDED TO REMOVE IT. GUIDELINER, ADDITIONAL WIRE, REPEAT BALLOONING. FINAL POST DILATION PERFORMED AT THE END WITH A SHORT LARGER BALLOON. THE DISTAL GRAFT ANASTOMOTIC SEGMENT WAS LEFT UNTOUCHED. GOOD FLOW POST PROCEDURE. WELL TOLERATED OVERALL. LEFT FEMORAL ACCESS CLOSED. DILATION OF THE LAD. LAD HAD ATHEROSCLEROSIS, CORONARY ARTERY CALCIFICATION. NO PATIENT COMPLICATIONS OR INJURY REPORTED. CURRENT CONDITION OF PATIENT IS REPORTED AS "FINE".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7468974 ↗
• InjuryApr 13, 2018Detachment Of Device Component; Detachment Of Device Component

  THE TIP OF THE TURNPIKE LP DID BREAK LOOSE IN THE LAO. DR. DID CAPTURE THE TIP OF THE TURNPIKE WITH THE WIRE. REPORTED THE LOA HAD ATHEROSCLEROSIS IN THE LOA ARTERY WITH (CAC) CORONARY ARTERY CALCIFICATION. REPORTED THAT THERE WAS NO PATIENT INJURY OR CONSEQUENCE, PATIENT CURRENT CONDITION IS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430410 ↗
• InjuryFeb 23, 2018Detachment Of Device Component; Detachment Of Device Component

  DURING A PROCEDURE, THE PHYSICIAN FOUND IT DIFFICULT TO TORQUE THE TURNPIKE LP MICROCATHETER AND TRIED TO RETRIEVE THE MICROCATHETER, AT WHICH POINT THE PROXIMAL HUB SEPARATED FROM THE MICROCATHETER. THE TIP OF THE TURNPIKE WAS NOT STUCK WHEN THE PHYSICIAN TRIED TO REMOVE IT. THE PROXIMAL END OF THE MICROCATHETER SHAFT WAS OUTSIDE THE PATIENT'S BODY, SO THE PHYSICIAN REMOVED THE DISTAL SHAFT WITHOUT USING AN EXTRA DEVICE. THERE WAS NO REPORTED HARM TO THE PATIENT, SO THE HOSPITAL DECLINED TO PROVIDE PATIENT INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7293503 ↗
• InjuryFeb 13, 2018Detachment Of Device Component; Detachment Of Device Component

  TIP BROKE OFF IN PATIENT. TIP WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7268025 ↗
• MalfunctionFeb 13, 2018Detachment Of Device Component; Detachment Of Device Component

  COMPLEX CASE WHERE THE TURNPIKE LP WAS USED FOR PERIPHERAL DISEASE IN THE RIGHT LOWER EXTREMITY. ACCESS FROM THE LEFT GROIN WAS OBTAINED. IT WAS IDENTIFIED THAT THE TURNPIKE WAS TORQUED BEYOND THE RECOMMENDED REVOLUTIONS WITHOUT ADVANCEMENT OF THE CATHETER. THE TURNPIKE CATHETER TIP SEPARATED FROM THE CATHETER. THE TURNPIKE CATHETER TIP SEPARATED FROM THE CATHETER, HOWEVER, THE TIP CAME OUT OF THE PATIENT ON THE GUIDEWIRE, AND NOTHING WAS LEFT IN THE PATIENT, AND NO HARM TO THE PATIENT WAS NOTED. PROCEDURE WAS ABORTED AFTER TURNPIKE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7267845 ↗
• InjuryJan 3, 2018Detachment Of Device Component; Detachment Of Device Component

  DURING A RETROGRADE PROCEDURE, THE TIP OF MICRO CATHETER WAS KINKED, THE JUNCTION BETWEEN TAPERED AND NON-TAPERED PART GOT "DECOILED'. IT WAS IMPOSSIBLE TO RETRIEVE THE WIRE. THE PHYSICIAN HAS ASSUMED THAT THE JUNCTION BETWEEN TAPERED AND NOT TAPERED MICROCATHETER SHAFT WAS DECOILED BECAUSE HE WAS NOT ABLE TO PULL BACK ONLY THE GUIDEWIRE. DURING SURGICAL INTERVENTION, THE OPERATOR WAS ABLE TO PULL BACK THE MICRO-CATHETER AND WIRE TOGETHER, WITHOUT INJURY TO SEPTAL COLLATERALS. THE PROCEDURE WAS CONCLUDED WITH SUCCESS.

  Patient problems: Embolism; No Known Impact Or Consequence To Patient

  MAUDE report 7159977 ↗
• MalfunctionOct 18, 2017Detachment Of Device Component; Detachment Of Device Component

  HUB PORTION OF CATHETER SEPARATED FROM SHAFT. NO PATIENT IMPACT REPORTED. ASSOCIATED TO MDR 2134812-2017-00080.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958035 ↗
• MalfunctionOct 18, 2017Detachment Of Device Component; Detachment Of Device Component

  HUB PORTION OF CATHETER SEPARATED FROM SHAFT. PHYSICIAN SAYS HE DID NOT PUSH CATHETER BEYOND LIMITS OF HOW HE HAS USED IN THE PAST. NO PATIENT IMPACT REPORTED. ASSOCIATED TO MDR 2134812-2017-00081

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6957947 ↗
• MalfunctionSep 20, 2017Detachment Of Device Component; Detachment Of Device Component

  CALCIFIED LESION WHERE ONLY WIRE WOULD PASS. DR. TRIED REGULAR TURNPIKE THEN TURNPIKE GOLD TO GET A CATHETER PAST THE LESION TO NO AVAIL. HE THEN TRIED THE TURNPIKE LP. AGAIN HE PUSHED THE CATHETER WHILE TORQUING, THE TURNPIKE LP NOSED INTO THE LESION BUT DID NOT PASS THROUGH THE LESION. AFTER REMOVAL OF THE TURNPIKE LP, IT WAS NOTED A RADIOPAQUE PIECE ON THE WIRE. DR. TRIED SNARING AND BUDDY WIRE TO REMOVE THIS PIECE, BUT THE LESION WAS SO TIGHT STILL NOTHING WOULD NAVIGATE PAST. DR. REMOVED WIRE SLOWLY UNDER FLURO AND PIECE CAME OUT OF BODY WITH THE WIRE. THE EXTRA PIECE NOW THOUGHT TO BE TIP OF TURNPIKE LP IS ON THE WIRE SENT WITH DEVICE FOR INSPECTION. EVENT WAS RESOLVED WHEN DETACHED TURNPIKE TIP WAS REMOVED ON THE WIRE AS WIRE WAS REMOVED. LESION WAS THEN PASSED WITH ROTO WIRE AND SUBSEQUENT ARTHRECTOMY PERFORMED WITH GOOD RESULT TO ARTERY AND GOOD RESULT FOR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6878360 ↗
• InjuryAug 30, 2017Detachment Of Device Component; Detachment Of Device Component

  PHYSICIAN WAS IN A TORTUROUS PART OF THE LESION AND WAS TRYING TO PROGRESS THE CATHETER. IN ORDER TO MANEUVER CATHETER IT WAS PULLED BACK AND IT WAS NOTICED THE TIP HAD BROKEN OFF. BROKEN TIP PUSHED TO DISTAL END OF THE ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6831566 ↗
• MalfunctionJun 28, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING AN ANGIOPLASTY PROCEDURE, IN ORDER TO CROSS A VERY CALCIFIED LESION, PHYSICIAN USED A BALLOON WITH DIAMETER OF 1.0MM AND A MICRO GUIDE CATHETER. HOWEVER BOTH WERE UNSUCCESSFUL. HENCE, THE PHYSICIAN USED THE TURNPIKE LP 150CM, AND ROTATED FOR ~5 MINS IN ORDER TO CROSS THE LESION. HOWEVER, THE LESION STILL CANNOT BE CROSSED. FINALLY PHYSICIAN DECIDED NOT TO USE THE TURNPIKE LP AND PULL OUT THE TURNPIKE LP (TOGETHER WITH GUIDEWIRE). WHEN THE TURNPIKE LP AND THE GUIDEWIRE WERE PULLED OUT OF THE PATIENT BODY, THE PHYSICIAN FOUND THAT THERE IS SOME EXTRA MATERIAL (LIKE PLASTIC) ON THE GUIDEWIRE CLOSE TO THE TIP OF THE TURNPIKE LP. PHYSICIAN SUSPECTED THE EXTRA MATERIALS ON THE GUIDEWIRE CAME FROM THE TIP OF THE TURNPIKE LP. NO ADVERSE EVENT FOUND WITH PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6673971 ↗
• InjuryApr 5, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING A CTO PROCEDURE, THE LP WAS ADVANCED INTO A SEVERELY CALCIFIED LESION. AS THE PHYSICIAN ENGAGED THE LP INTO THE LESION, THE CATHETER WAS UNABLE TO ADVANCE THROUGH THE LESION AND BECAME STUCK. AFTER MULTIPLE ATTEMPTS TO DISENGAGE THE LESION, THE CATHETER WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED PART OF THE CATHETER TIP WAS "SHREDDED" AND PART OF THE TIP IS NOT VISIBLE. DECISION WAS MADE TO STOP THE PROCEDURE AND TO BRING THE PATIENT BACK WITH A NEW STRATEGY AT A LATER DATE. ADDITIONAL INFORMATION RECEIVED 05APR2017: THIS WAS A CASE IN WHICH NO DEVICE WOULD PASS THROUGH THE CTO DURING THE PROCEDURE. THE REASON THEY RESCHEDULED IS BECAUSE THEY HAD TRIED SO MANY DEVICES AND WERE BEGINNING TO GET FATIGUED AND DECIDED THE PATIENT HAD BEEN ON THE TABLE LONG ENOUGH. THEY WANTED TO COME BACK TO ANOTHER PROCEDURE SO THEY COULD TRY A LASER ATHERECTOMY, WHICH WASN'T AVAILABLE THE DAY OF THE ORIGINAL CASE. AS FAR AS THE TURNPIKE LP TIP, THE TIP DID SEPARATE, BUT CAME OUT ON THE WIRE AND WAS NOT LEFT IN THE PATIENT'S BODY. IT WAS CONFIRMED TO BE THROWN AWAY AFTER THE CASE. NO ADDITIONAL PROCEDURE WAS NEEDED DUE TO THE TURNPIKE TIP SEPARATION.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6461261 ↗
• DeathDec 21, 2016Detachment Of Device Component; Detachment Of Device Component

  CTO OF LEFT VENA, STUCK IN SEPTUM, TIP OF CATHETER BROKE: DURING THE TREATMENT OF AN RCA CTO USING A RETROGRADE APPROACH, PHYSICIAN HAD TO REMOVE A (FIRST) TURNPIKE LP CATHETER DUE TO THE LOSS OF GUIDEWIRE MOVEMENT AFTER APPLYING SIGNIFICANT TORQUE TO THE DEVICE. HE SUBSEQUENTLY WENT BACK IN WITH A SECOND TURNPIKE LP AND ALSO LOST WIRE MOVEMENT. HE REMOVED ONE GUIDEWIRE AND TRIED TO RE-ADVANCE A SECOND WIRE. HE WAS UNABLE TO ADVANCE THE SECOND WIRE. DURING A SUBSEQUENT ATTEMPT TO WITHDRAWAL OF THE TURNPIKE SIGNIFICANT RESISTANCE WAS ENCOUNTERED. AFTER APPLYING CLOCKWISE AND COUNTERCLOCKWISE ROTATIONS THE CATHETER SHAFT DETACHED LEAVING A PORTION OF THE TURNPIKE CATHETER IN THE SEPTAL AND A PORTION INTO THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN FELT THAT HE HAD OVER ROTATED THE CATHETER BEYOND THE DEVICE'S LIMITS. THE PATIENT WAS SENT TO SURGERY, THE CATHETER WAS REMOVED AND THE PATIENT RECEIVED CORONARY ARTERY BYPASS INSTEAD OF THE PLANNED CTO-PCI. THE PATIENT IS REPORTED TO BE DOING FINE. RECEIVED (B)(6) 2016: NEW INFORMATION REGARDING THIS CASE. WE HAVE BECOME AWARE THAT THE PT. SUDDENLY DETERIORATED AND BECAME HYPOTENSIVE. THE SURGEON HAD TO OPEN HER UP IN THE CCU, BUT

  Patient problems: Death

  MAUDE report 6195513 ↗