RAIDER IPN913607Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841156101275), received between Dec 29, 2020 and Apr 14, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: 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: 2134812-2021-00033 TURNPIKE SMOOTH. 2134812-2021-00034 TURNPIKE LP.

  Patient problems: Hematoma; Perforation

  MAUDE report 11668191 ↗
• InjuryApr 14, 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 MID-LCX, THE SUBJECT SUFFERED AN ELLIS II PERFORATION OF THE TARGET VESSEL WITH A RAIDER GUIDEWIRE (STUDY DEVICE). THERE WAS FREE FLOWING PERICARDIAL EFFUSION, CIRCUMFERENTIAL BUT LARGEST ANTERIORLY WITH HEMATOMA FORMATION POST PROLONGED BALLOON INFLATION. SUBJECT WAS HYPERTENSIVE DURING THE EVENT. TREATED WITH PROLONGED BALLOON INFLATION WITH RESIDUAL DISSECTION NOTED. RESOLVED WITHOUT FURTHER SEQUELAE. NO ADVERSE EVENTS WERE REPORTED AT STUDY 30-DAY FOLLOW-UP VISIT.

  Patient problems: Perforation

  MAUDE report 11668175 ↗
• InjuryMar 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED: DURING THE STUDY 30-DAY CONDUCTED ON (B)(6) 2021 IT WAS REPORTED THAT 3 DAYS POST-PROCEDURE THE PATIENT SUFFERED NEW ONSET OF A-FIB WITH RATES TO 120 BPM AND FREQUENT PVCS. THIS NEW ONSET OF A-FIB IS PROBABLY ATTRIBUTED TO THE VOLUME OVERLOAD AND MYOCARDIAL MANIPULATION PERFORMED DURING THE INDEX PROCEDURE PERFORMED ON (B)(6) 2021 OF A CTO PCI OF THE PROXIMAL RCA IN WHICH A TURNPIKE (STUDY DEVICE), TRAPLINER (STUDY DEVICE), SPECTRE GUIDEWIRE (STUDY DEVICE) AND RAIDER GUIDEWIRE (STUDY DEVICE) WERE USED. PATIENT WAS TREATED WITH SYNC-CARDIOVERSION AND MEDICAL MANAGEMENT WITH AMIODARONE LOAD. THIS EVENT WAS RESOLVED WITH NO SEQUELAE. MDRS ASSOCIATED TO: MDR 2134812-2021-00018 SPECTRE GW, MDR 2134812-2021-00019 TRAPLINER, MDR 2134812-2021-00020 TURNPIKE LP.

  Patient problems: Atrial Fibrillation

  MAUDE report 11448986 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS UNIT WAS USED DURING A CTO PCI STUDY CASE ON SUBJECT (B)(6). NO NEW ADVERSE EVENTS REPORTED AT THE 30-DAY STUDY CLOSE-OUT VISIT DURING A CTO PCI PROCEDURE OF THE RCA, IT IS REPORTED THAT THE PATIENT SUFFERED A PERFORATION OF THE RCA RESULTING IN A MYOCARDIAL INFARCTION AND RIGHT VENTRICULAR FAILURE. AT THE TIME OF THE PERFORATION A BANDIT GUIDEWIRE (STUDY DEVICE) AND A RAIDER GUIDEWIRE (STUDY DEVICE) WAS INSERTED INTO THE RCA VIA THE ANTEGRADE APPROACH. A TURNPIKE SPIRAL (STUDY DEVICE) WAS POSITIONED IN THE SEPTAL VIA THE RETROGRADE APPROACH. POST DEPLOYMENT OF A DES STENT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE REQUIRING NEED FOR COMPRESSIONS, INTUBATION AND INSERTION OF A TVP PLACED IN THE RV APPENDAGE WITH PATIENT SUBSEQUENTLY RECOVERING. AGAIN, PATIENT BECAME HEMODYNAMICALLY UNSTABLE WITH NEED FOR CARDIOVERSION. ECHO AT BEDSIDE SHOWED STUNNED LV AND RV AND EFFUSION FROM PERFORATION IN THE RCA. PROLONGED BALLOON INFLATION AND DEPLOYMENT OF 3 COVERED STENTS (4.0 X 26, 5.0 X 26 AND 5.0X20 RESPECTIVELY) STABILIZED THE PERFORATION. PATIENT STABILIZED AND PROCEDURE CONTINUED WITHOUT FURTHER INCIDENCE. A TEMPORARY PACEMAKER WAS IMPLANTED FOR POST-PROCEDURE AND PATIENT WAS EXT

  Patient problems: Cardiac Perforation

  MAUDE report 11385856 ↗
• 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 TODETERIORATE. 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 11088522 ↗