SPECTRE IPN914920Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841156106508), received between Oct 13, 2020 and Apr 14, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 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

  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 2134812-2021-00039 SPECTRE GUIDEWIRE. MDR 2134812-2021-00040 TURNPIKE SPIRAL. MDR 2134812-2021-00041 WARRIOR GUIDEWIRE.

  Patient problems: Extravasation; Perforation

  MAUDE report 11668291 ↗
• InjuryApr 14, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED: A SMALL PERFORATION WAS NOTED ON A POST-PROCEDURE ECHO THAT WAS NOT NOTED DURING THE SUCCESSFUL PROCEDURE OF A CTO-PCI OF A PROXIMAL, NON-TORTUOUS, MODERATELY CALCIFIC CTO IN THE RCA ON STUDY SUBJECT (B)(6). MANY DEVICES, BOTH STUDY AND NON-STUDY DEVICES WERE USED. IT IS UNKNOWN WHAT DEVICE USED DURING THE PROCEDURE, WHICH INCLUDED STUDY DEVICES OF A TURNPIKE SPIRAL MICROCATHETER AND A SPECTRE GUIDEWIRE, CAUSED THE PERFORATION. THE SUBJECT DID NOT BECOME HEMODYNAMICALLY UNSTABLE AND IT WAS FELT THAT THE PERFORATION OCCURRED DURING RETROGRADE ATTEMPT TO CROSS THE LESION. SUBSEQUENT ECHOS DONE POST-PROCEDURE AND PRIOR TO DISCHARGE SHOWED SMALL PERICARDIAL EFFUSION ADJACENT TO RV FREE WALL WITH NO EVIDENCE OF TAMPONADE. SUBJECT DISCHARGED NEXT DAY, RESOLVED WITHOUT SEQUELAE. ASSOCIATED MDR 2134812-2021-00036 TURNPIKE SPIRAL.

  Patient problems: Perforation

  MAUDE report 11668211 ↗
• InjuryMar 10, 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 2134812-2021-00017 RAIDER GW. MDR 2134812-2021-00019 TRAPLINER. MDR 2134812-2021-00020 TURNPIKE LP.

  Patient problems: Atrial Fibrillation

  MAUDE report 11457183 ↗
• 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 (B)(6) 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 11088582 ↗
• InjuryOct 13, 2020Break; Break

  AS REPORTED: UPON REWIRING NEWLY DEPLOYED STENT, WIRE GOT TRAPPED BEHIND STENT WALL AND PHYSICIAN WAS UNABLE TO REMOVE WIRE. PHYSICIAN INTENTIONALLY BROKE WIRE TIP OFF AND PINNED REMAINING PIECE BEHIND THE STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10669224 ↗