WARRIOR IPN914142Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156101152), received between Dec 29, 2020 and Apr 14, 2021 — classified as 1 death, 1 injury.

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 2 most recent of 2 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

  DURING A CTO PCI INDEX PROCEDURE FOR THE CTO-PCI STUDY OF A SEVERELY CALCIFIC NON-TORTUOUS LESION LOCATED IN THE PROX. LAD, THE SUBJECT SUFFERED AN ELLIS I PERFORATION. MANY DEVICES WERE USED DURING THE PROCEDURE, BOTH STUDY AND NON-STUDY AND IT WAS FELT THAT PERFORATION WAS DUE TO CATHETER COURSE, BUT IT IS UNKNOWN WHICH DEVICE CAUSED THE PERFORATION. STUDY DEVICES USED IN THE PROCEDURE INCLUDED A TURNPIKE SPIRAL MICROCATHETER, SPECTRE 200 CM AND 300 CM GUIDEWIRES, A RAIDER GUIDEWIRE, AND A WARRIOR GUIDEWIRE. SUBJECT SHOWED NO SIGNS OR SYMPTOMS OVERTLY AND POSSIBLE EXTRAVASATION WAS NOTED ON ONE ANGIOGRAM. PROLONGED BALLOON INFLATION WAS PERFORMED IN SUSPECTED AREA PROPHYLACTICALLY, BUT NOT SPECIFICALLY FOR TAMPONADE OR PERFORATION, PROTAMINE WAS ADMINISTERED TO REVERSE ANTICOAGULATION. POST-PROCEDURE TEE SHOWED NO EFFUSION. SUBJECT DISCHARGED HOME NEXT DAY, RESOLVED WITHOUT FURTHER SEQUELAE. NO ADVERSE EVENTS WERE REPORTED AT STUDY 30-DAY FOLLOW-UP VISIT. ASSOCIATED MDRS: MDR 2134812-2021-00037 RAIDER GUIDEWIRE. MDR 2134812-2021-00038 SPECTRE GUIDEWIRE. MDR 2134812-2021-00039 SPECTRE GUIDEWIRE. MDR 2134812-2021-00040 TURNPIKE SPIRAL.

  Patient problems: Extravasation; Perforation

  MAUDE report 11668304 ↗
• 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 11088810 ↗