TURNPIKE IPN039141Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10841156105051), received between Oct 14, 2020 and May 10, 2021 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: DURING USE ON PATIENT THE CATHETER INSERTED DOWN CALCIFIED RCA AND TIP BROKE OFF AND REMAINED IN THE VESSEL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: Foreign Body Embolism; Insufficient Information

  MAUDE report 11799272 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A SUCCESSFUL PCI TO A NON-TORTUOUS, MODERATELY CALCIFIC CTO OF THE PROXIMAL RCA ON CTO PCI STUDY SUBJECT (B)(6), SUBJECT SUFFERED AN ELLIS GRADE 1 VESSEL PERFORATION TO AN EPICARDIAL COLLATERAL FROM THE CFX WHICH RESULTED IN A RESIDUAL HEMATOMA. MANY DEVICES, BOTH STUDY AND NON-STUDY, WERE USED IN THE PROCEDURE. STUDY DEVICES INCLUDED A TURNPIKE MICROCATHETER, TURNPIKE LP MICROCATHETER AND A RAIDER GUIDEWIRE. IT IS UNKNOWN WHICH DEVICE CAUSED THE PERFORATION BUT FELT TO BE CAUSED BY A NON-STUDY DEVICE. PERFORATION TREATED WITH COIL EMBOLIZATION (0.014" COILS X 2) WITH RESOLUTION, HEMATOMA TREATED WITH CUTTING BALLOON WITH MODERATE SUCCESS OF DECOMPRESSION AND SMALL RESIDUAL HEMATOMA. TEE PERFORMED PRIOR TO DISCHARGE SHOWED NO PERICARDIAL EFFUSION. DISCHARGED HOME NEXT DAY WITH NO FURTHER SEQUELAE. ASSOCIATED TO MDRS: 2134812-2021-00032 RAIDER GW. 2134812-2021-00033 TURNPIKE SMOOTH.

  Patient problems: Hematoma; Perforation

  MAUDE report 11667960 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: DURING A CTO PCI INDEX PROCEDURE FOR THE CTO-PCI STUDY OF A LONG, SEVERELY CALCIFIC NON-TORTUOUS LESION LOCATED IN THE PROX. LAD, THE SUBJECT SUFFERED AN ELLIS III PERFORATION OF THE DISTAL LAD WHILE ATTEMPTING TO TRAVERSE RETROGRADE WITH A TURNPIKE LP MICROCATHETER (STUDY DEVICE). PERFORATION APPEARED TO BE LARGELY CONTAINED AND STAINING INTO FAT. NO ACTIONS WERE TAKEN AND RESULTED IN VESSEL HEMATOMA AND RESIDUAL DISSECTION NOTED. RESOLVED WITHOUT FURTHER SEQUELAE. NO ADVERSE EVENTS WERE REPORTED AT STUDY 30-DAY FOLLOW-UP VISIT.

  Patient problems: Perforation

  MAUDE report 11655055 ↗
• MalfunctionMar 5, 2021Use of Device Problem; Use of Device Problem

  AS REPORTED: DURING RETROGRADE CTO PCI OF THE PROXIMAL RCA, A SEPTAL HEMATOMA WAS NOTED ON ANGIOGRAPHY. PROCEDURE BEING PERFORMED WAS REVERSE CART AND THE SITE FELT THAT THE HEMATOMA WAS CAUSED BY A GUIDEWIRE WHICH WAS INSERTED INTO THE SEPTAL VIA A TURNPIKE LP MICROCATHETER (STUDY DEVICE). THOUGH THE SITE STATED THAT THE GUIDEWIRE WAS THE CAUSE OF THE SEPTAL HEMATOMA, IT IS UNCLEAR WHICH DEVICE WAS RESPONSIBLE. THE PATIENT SUFFERED NO ADVERSE EFFECTS AND WAS DISCHARGED HOME WITH NO SEQUELAE.

  Patient problems: Hematoma

  MAUDE report 11425629 ↗
• DeathDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT EXPIRED POST INDEX PROCEDURE IN THE CTO PCI STUDY IN WHICH NUMEROUS DEVICES WERE USED. AT THE END OF THE INDEX PROCEDURE A PERFORATION WAS NOTED WHICH WAS TREATED WITH A COVERED STENT. ECHOCARDIOGRAM SHOWED STABLE PERICARDIAL EFFUSION W/O TAMPONADE. DURING EVENING POST-PROCEDURE SUBJECT WAS ON BEDSIDE COMMODE C/O NAUSEA WAS GIVEN A BASIN FOR EMESIS, HOWEVER HE COLLAPSED WAS BROUGHT BACK TO BED WHERE HE WAS FOUND PULSELESS. CPR AND ACLS PROTOCOLS WERE INITIATED. BEDSIDE CANNULATION OF VA ECMO CIRCUIT W/ PERFUSION AND TVP WAS PLACED. BEDSIDE TEE DEMONSTRATED STABLE PERICARDIAL EFFUSION W/O EVIDENCE OF TAMPONADE. SUBJECT WAS EMERGENTLY BROUGHT DOWN TO CATH LAB FOR CORONARY REPERFUSION. LMCA, LAD LCX OM1 AND OM2 THROMBOSED, S/P PTCA AND ASPIRATION THROMBECTOMY RESTORED TIMI3 FLOW TO LMCA, PROX LAD, LCX, OM1 AND OM2, NO FLOW TO DISTAL LAD DESPITE THROMBECTOMY, PTCA AND VASODILATOR PHARMACOTHERAPY. UPON RETURN FROM CATH LAB PATIENT CONTINUED TO DETERIORATE. SUBJECT SHOWED SIGNS OF HEPATIC AND RENAL FAILURE REQUIRING SLED. 4U PRBC FOR SIGNIFICANT ANEMIA WAS GIVEN (HGB 6.1 WITH MINIMAL IMPROVEMENT AFTER TRANSFUSION). VA ECMO RPM WAS INCREASED TO 4000 WITH IMPROVEMENT IN FLOWS (3.4-

  Patient problems: Perforation

  MAUDE report 11088658 ↗
• InjuryOct 14, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED: THE TURNPIKE LP WAS OVER THE INTERVENTIONAL GUIDEWIRE AND RESISTANCE WAS FELT, IT BECAME STUCK ON THE WIRE. THE TURNPIKE LP WAS REPORTED AS ROTATING A "HALF A DOZEN TIMES" IN EACH DIRECTION AND KINKED. THE WIRE COULD NOT BE PULLED OFF AS USUAL AND REQUIRED TO BE CUT. THE TURNPIKE LP WAS REMOVED WITH THE WIRE, THE WIRE TIP BROKE AND REMOVED BY A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10677527 ↗