TURNPIKE IPN913576Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841156100681), received between Mar 25, 2020 and May 9, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Material Separation; Material Separation

  IT WAS REPORTED BY CLINICAL STAFF THAT: "WIGGLE WIRE STUCK BEHIND NEWLY PLACED STENT. INSERTED TURNPIKE LP TO FACILITATE RELEASE OF THE WIRE. TIP OF THE TURNPIKE APPEARS TO HAVE CLAMPED DOWN ON OR FUSED TO THE WIRE. UPON REMOVAL OF THE TURNPIKE LP FROM THE BODY IT WAS NOTED THAT PART OF THE TIP DETACHED FROM THE TURNPIKE LP AND REMAINED ON THE WIRE INSIDE THE BODY. THEN LASER WAS USED. VESSEL DISSECTED. PT CODED. PT PLACED ON ECMO. AFTER THE ECMO WAS IN PLACE THE WIRE AND THE TIP OF THE TURNPIKE THAT WAS STUCK, WAS RELEASED USING A GUIDE EXTENSION. THE PART OF THE TIP THAT HAD BROKEN OFF WAS STILL ON THE WIRE AND COMPLETELY REMOVED FROM THE PATIENT ALONG WITH THE WIRE. THE FRESH STENT THAT HAD BEEN PLACED WAS ALSO REMOVED ALONG WITH THE WIRE. NEW STENT PLACED. CASE COMPLETED. PT TRANSFERRED." ADDITIONAL INFORMATION: "THE USE OF THE TURNPIKE LP AND THE LASER WERE BOTH USED AS AN INTERVENTION DUE TO THE WIGGLE WIRE BEINGS PINNED AND UNABLE TO BE REMOVED FROM BEHIND A FRESHLY PLACED STENT. MULTIPLE DEVICES WERE USED TO REMOVE THE WIRE. DURING THIS PROCESS THE VESSEL DISSECTED, AND PATIENT CODED. THIS LED TO CPR AND EVENTUALLY ECMO. THE PATIENT WAS REPORTED AS DECEASED APPROXIMATELY 8-

  Patient problems: Foreign Body In Patient

  MAUDE report 19276354 ↗
• InjuryJan 17, 2024Material Separation; Material Separation

  DR. WAS ATTEMPTING TO CROSS A TIGHT LAD LESION DURING ATHERECTOMY. HE ATTEMPTED CROSSING WITH A BALLOON AND TPK LP 135. WHEN TRYING TO REMOVE THE TURNPIKE, THE TIP BROKE OFF IN THE PATIENT. THEY TRIED USING PRONTO TO SUCK IT OUT- UNSUCCESSFULLY. AS OF NOW, THEY HAVE CONSULTED WITH THE SURGEONS AND HAVE DECIDED TO LEAVE IT IN THE PATIENT FOR NOW. PATIENT IS STILL IN ICU. THEY ARE OK AS PER CATH LAB MANAGER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18524282 ↗
• MalfunctionMar 25, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE DEVICE FAILED TO PERFORM ITS FUNCTION. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED 26FEB2020: THE EVENT OCCURRED DURING CX CTO RE-CANALIZATION (IN-STENT RESTENOSIS) WITHOUT ANY ACTUAL FEEDBACK (NO RESISTANCE) DURING TORQUEING AND THE MICRO-CATHETER (MC) GOT STUCK INSIDE TURNPIKE LP. THERE WAS NO POSSIBILITY TO MOVE WIRE INSIDE MC AND FINALLY BOTH DEVICES (WIRE WITH MC) HAD TO BE REMOVED FROM THE VESSEL. AFTER VISUAL INSPECTION CATHETER WAS TWISTED AROUND WIRE. THE MAIN POINT WAS NO PERCEPTIBLE RESISTANCE WHEN MC GOT STUCK AND STARTED TO TWIST. NO FURTHER COMPLICATIONS WERE REPORTED. MANUFACTURER INVESTIGATION WAS PERFORMED ON 16MAR2020 AND IT WAS NOTED THAT THERE WAS TIP DAMAGE/SEPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9878533 ↗