TURNPIKE IPN039142Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10841156105082), received between Aug 28, 2020 and Mar 15, 2023 — classified as 1 death, 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: "PARTIAL DETACHMENT OF DISTAL TIP, RECOVERED WITH NO PATIENT INCIDENT. THE INSERTION SITE WAS RADIAL ARTERY. CLINICAL CONSEQUENCES: TURNPIKE GOLD INSERTED TO REPLACE AND CASE PROCEEDED TO A SUCCESSFUL OUTCOME. THE DEVICE WAS REMOVED ENTIRELY AND REPLACED. ANOTHER ATTEMPT WAS MADE SUCCESSFULLY. THIS DID NOT CAUSE DELAY OR HARM/INJURY TO THE PATIENT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16543780 ↗
• InjuryFeb 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT: THE PHYSICIAN FOUND THE PRODUCT FAILED TO ADVANCE THE CALCIFIED LEGION DURING PCI SO WHILE THE PHYSICIAN WAS REMOVING THE CATHETER BACK, THE TIP GOT SPLIT AND STUCK IN THE PATIENT S BLOOD VESSEL. ADDITIONAL INFORMATION ON (B)(6) 2023, DURING A PCI PROCEDURE ON THE (B)(6) 2023, THE ABOVE INCIDENT OCCURRED, THE CUSTOMER REPORTED THAT THE DEFECT MAY HAVE OCCURRED BECAUSE OF UNINTENTIONAL ERROR AND NO ISSUE WITH THE PRODUCT. THE PATIENT WAS REPORTED AS FINE POST PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT AND WILL BE ADDED TO THE FOLLOW UP REPORT ON RECEIPT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16425990 ↗
• MalfunctionDec 21, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT "TIP OF THE MICROCATHETER (TURNPIKE SPIRAL) DETACHED AND STAYED ENTRAPPED ON THE GUIDEWIRE. NEEDED TO REMOVE THE GUIDEWIRE OVER A GUIDE EXTENSION." ACTUAL COMPLAINT DEVICE IS AVAILABLE FOR INVESTIGATION. ADDITIONAL INFORMATION ON 08DEC2022: DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT ANTERIOR DESCENDING ARTERY(LAD), THERE WAS REPORTED DIFFICULTY DURING USE AND DURING REMOVAL OF THE TURNPIKE SPIRAL. AFTER THE TIP DETACHED THE DEVICE WAS REMOVED IN ITS ENTIRETY AND REPLACED. THE ISSUE WAS RESOLVED BY REMOVAL USING GUIDE EXTENSION. ANOTHER ATTEMPT WAS PERFORMED AND SUCCESSFUL. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS STABLE POST PROCEDURE AND HAD NO EXTENDED HOSPITAL STAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022158 ↗
• InjuryJun 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TURNPIKE SPIRAL DISTAL TIP GOT CAUGHT IN A CALCIFIED CHANNEL ON THE MEDIAN RCA AND DETACHED FROM THE BODY OF THE CATHETER. IT STAYED FIXED IN THE OCCLUSION AND DID NOT MIGRATE. THE OCCLUSION COULD NOT BE OPENED. NO CONSEQUENCE FOR THE PATIENT. THE PHYSICIAN DECIDED TO ABORT THE CASE AS THE VESSEL WAS TO DENSELY AND HARDILY CALCIFIED. ADDITIONAL INFORMATION ON (B)(6) 2022: TRIED TO SNARE IT OUT, BUT THEY COULD NOT AS THE DISTAL TIP WAS COMPLETELY STUCK IN THE OCCLUSION. IT WAS STUCK IN THE PROXIMAL CALCIUM CAP. THE CASE WAS STOPPED AS THE LESION WAS IMPENETRABLE AND RETROGRADE ACCESS WAS NOT POSSIBLE. PATIENT WAS STABLE. NO COMPLICATIONS FOR THE PATIENT. MEDICAL MANAGEMENT OF THE PATIENT'S SYMPTOMS WILL BE CONTINUED AND NO OTHER PROCEDURE IS PLANNED AT THIS TIME.

  Patient problems: Foreign Body Embolism

  MAUDE report 14844729 ↗
• InjuryMar 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: DURING PROCEDURE, PATIENT AO PRESSURE DROPPED DRAMATICALLY. PHYSICIAN REMOVED THE ALLEGED CATHETER AND FOUND THAT PART OF THE TIP WAS DISLODGED. THEN PHYSICIAN USED A SNARE TO TAKE OUT THE DISLODGED PART. FINALLY USED ANOTHER BRAND MICROCATHETER TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 13744536 ↗
• InjuryFeb 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: PHYSICIAN DOING A STENTING PROCEDURE IN THE HEART OF A PATIENT, AND THE TIP CAME OFF OF THE TURNPIKE SPIRAL DURING THE PROCEDURE. ANOTHER PHYSICIAN WAS CALLED IN AND THEY MADE THE DECISION TO LEAVE IT IN AND NOT REMOVE THE TIP OUT. NO INTERVENTION WAS PERFORMED, TIP WAS LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13455329 ↗
• InjuryDec 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: PCI (NON CTO), TIP OF CATHETER LODGED IN ARTERY (CIRC) AND UNABLE TO BE REMOVED. INCIDENT OCCURRED DURING THE PROCEDURE, INSIDE THE PATIENT. CLINICAL CONSEQUENCES: PATIENT STABLE NO - ST CHANGES, NO CHEST PAIN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS HALTED. PHYSICIAN MAY HAVE OVER TORQUED THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12980234 ↗
• InjuryJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THE TURNPIKE SPIRAL TIP BROKE OFF INSIDE THE RCA DURING ADVANCEMENT. A WIRE WAS INSERTED IN THE SUBINTIMAL SPACE AT THE LOCATION OF THE DISTAL CAP. ONCE THE WIRE WAS SUCCESSFULLY DOWN THE VESSEL, THE TURNPIKE SPIRAL WAS ADVANCED IN A VERY CALCIFIED LESION. IT WAS BEING TURNED CLOCKWISE TO ADVANCE. THE CATHETER WAS NOT MOVING FORWARD AND WAS PULLED BACK AND RE-ENGAGED THE VESSEL. DURING ATTEMPTED ADVANCEMENT THE TIP BECAME SEPARATED FROM THE SHAFT OF THE CATHETER. IT WAS STILL ATTACHED TO THE WIRE. PHYSICIAN ATTEMPTED TO REMOVE THE WIRE, BUT THE TIP REMAINED IN PLACE AND WAS NOT FUSED TO THE WIRE. PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO ADD A SECOND WIRE ALONGSIDE THE EXISTING WIRE. THIS WAS NOT SUCCESSFUL. DURING SEVERAL HOURS MULTIPLE DEVICES WERE USED TO TRY TO RETRIEVE THE TIP. ASPIRATION, SNARE, SEPARATE MICRO CATHETER. NONE OF THESE WERE SUCCESSFUL. THE DECISION WAS MADE TO REMOVE THE WIRE AND LEAVE THE TIP IN PLACE. THE PATIENT WILL BE BROUGHT BACK FOR A RETROGRADE CTO IN ATTEMPT TO OPEN THE VESSEL AND JAIL THE TIP WITH A STENT. THIS WAS A CTO, SO BLOOD FLOW WAS NOT IMPEDED BECAUSE THERE WAS NO FLOW TO BEGIN WITH. THE PATIENT RECOVERED WELL WITH NO ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12061518 ↗
• 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 GW. MDR 2134812-2021-00038 SPECTRE GUIDEWIRE. MDR 2134812-2021-00039 SPECTRE GUIDEWIRE. MDR 2134812-2021-00041 WARRIOR GUIDEWIRE.

  Patient problems: Extravasation; Perforation

  MAUDE report 11668320 ↗
• 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 010-015. 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: MDR 2134812-2021-00035 SPECTRE GUIDEWIRE.

  Patient problems: Perforation

  MAUDE report 11667961 ↗
• InjuryApr 8, 2021Separation Problem; Separation Problem

  AS REPORTED: PHYSICIAN USED A TURNPIKE SPIRAL AND DURING THE PROCEDURE A PIECE OF THE BLACK TIP SEPARATED FROM THE END AND WAS IN THE LEFT MAIN. THEY WERE UNABLE TO RETRIEVE USING A SNARE, SO THEY PLACED A STENT IN THE LEFT MAIN TO KEEP THE PIECE OF THE TIP IN PLACE AGAINST THE WALL OF THE ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11638248 ↗
• 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 2134812-2021-00018 SPECTRE GW. MDR 2134812-2021-00019 TRAPLINER.

  Patient problems: Atrial Fibrillation

  MAUDE report 11457151 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS UNIT WAS USED DURING A (B)(6) STUDY CASE ON SUBJECT (B)(6). NO NEW ADVERSE EVENTS REPORTED AT THE 30-DAY STUDY CLOSEOUT VISIT. DURING A (B)(6) 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 EXTUB

  Patient problems: Cardiac Perforation

  MAUDE report 11386825 ↗
• 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: Abdominal Distention; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Collapse; Death; Loss Of Pulse; Nausea; Perforation; Pericardial Effusion; Renal Failure

  MAUDE report 11088742 ↗
• InjuryNov 17, 2020Material Fragmentation; Material Fragmentation

  A REPORTED: PHYSICIAN INSERTED TURNPIKE SPIRAL, GOING ANTEGRADE. PHYSICIAN WAS NOT IN THE VESSEL FOR MORE THAN 5 MINUTES. PHYSICIAN REMOVED THE MICROCATHETER AND NOTICED TURNPIKE SPIRAL THREAD WAS HALF-OFF THE DISTAL TIP, DETACHED THREAD WAS REMOVED BY SNARING. PATIENT WAS REPORTED AS FINE AND DISCHARGED SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10856342 ↗
• InjuryNov 16, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: SEVERE CALCIFICATION IN DM2/ LCA, AFTER USING TP LP, TP GOLD AT LEAST TP SPIRAL IN TURNING CLOCKWISE A VERY LITTLE PART OF THE TIP WAS CUT. CLARIFICATION FROM OUR CLINICAL TEAM 05NOV2020: THE PATIENT HAD A LONG STENOSIS/LESION IN THE DISTAL PORTION OF THE 2ND DIAGONAL WHICH ORIGINATES FROM THE LEFT ANTERIOR DESCENDING ARTERY WHICH ORIGINATES FROM THE LEFT CORONARY ARTERY. THE INITIAL PLAN AFTER VISUALIZING THE STENOSIS WAS TO USE THE TURNPIKE LP TO AID IN WIRE PLACEMENT AND THEN ROTOBLATE THE STENOSED AREA. A GUIDE CATHETER WAS PLACED IN THE OSTIUM OF THE LEFT CORONARY ARTERY, AND THE TURNPIKE LP WAS ADVANCED OVER THE GUIDEWIRE TO THE PROXIMAL EDGE OF THE STENOSIS. DUE TO HEAVY CALCIFICATION, THE PHYSICIAN WAS UNABLE TO ADVANCE THE TURNPIKE LP/GUIDEWIRE ANY FURTHER, SO THE TURNPIKE LP WAS REMOVED, AND A NON-COMPLIANT BALLOON WAS INSERTED. USING THE NON-COMPLIANT BALLOON THE PHYSICIAN ATTEMPTED TO DILATE THE VESSEL BUT HAD MINIMAL SUCCESS, SO THE BALLOON WAS REMOVED. AT THAT TIME THE PHYSICIAN INSERTED THE TURNPIKE GOLD OVER THE GUIDEWIRE AND WAS ABLE TO ADVANCE IT AND THE WIRE PASSED THE PROXIMAL EDGE OF THE STENOSIS TOWARD THE DISTAL PORTION OF THE STENOSIS AND VESSEL

  Patient problems: Foreign Body In Patient

  MAUDE report 10847984 ↗
• MalfunctionNov 16, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: IT WAS FOR A COMPLEX ANGIOPLASTY PROCEDURE OF THE LEFT CORONARY ARTERY, HIGHLY CALCIFIED LESION OF THE CIRCUMFLEX ARTERY. THERE WAS AN ATTEMPT TO CLEAR THE LESION BY TORQUE MOVEMENT OF A TURNPIKE SPIRAL ON A GUIDEWIRE. QUICKLY THE END OF THE MICROCATHETER BROKE AND ONE END OF THE SOFT TUNGSTEN END REMAINED HOOKED TO THE GUIDE. THE TURNPIKE SPIRAL, AND GUIDE SET WAS REMOVED AND THE PROCEDURE WAS STOPPED. THERE WAS NO CONSEQUENCE FOR THE PATIENT. THE BROKEN TIP OF THE TURNPIKE SPIRAL STAYED ON THE GUIDE, ALL HAS BEEN REMOVED FROM THE PATIENT, NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10844984 ↗
• InjuryOct 16, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: THE TIP OF THE TURNPIKE SPIRAL CAME OFF DURING A COMPLEX PCI PROCEDURE. ADDITIONAL INFORMATION RECEIVED 25SEP2020: THE VESSEL; RCA, WAS SEVERELY CALCIFIED, NOT TORTUROUS. A VERY SMALL PORTION OF TIP FUSED TO A .014 GUIDEWIRE. IT WAS ACTUALLY SO SMALL THE PHYSICIAN WAS ABLE TO DELIVER A BALLOON OVER THE FUSED PORTION AND WHEN THE PROCEDURE WAS FINISHED IT WAS STILL ATTACHED TO GUIDEWIREWIRE. 7FR SYSTEM WAS USED DURING THE CASE AND DID NOT REPLACE WITH ANOTHER MICROCATHETER DUE TO RADIATION EXPOSURE BEING TOO HIGH TO PROCEED FORWARD. PHYSICIAN STATED, HE HAD MENTIONED THAT THE TURNPIKE SPIRAL FUSING TO THE WIRE COULD HAVE BEEN FROM USING A LASER CATHETER BEFOREHAND AND COULD HAVE POTENTIALLY CAUSED DISRUPTION TO THE WIRE (LOSS OF COATING, HEATING OF WIRE, ETC.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10688924 ↗
• InjurySep 11, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: PHYSICIAN STATED THE TIP OF THE CATHETER BROKE OFF IN A PATIENT PROCEDURE WITH A HEAVILY CALCIFIED VESSEL. TIP WAS LEFT BEHIND STENT, IT REPORTED THAT THE TIP REMNANT WAS "EXCLUDED" FROM THE RECONSTRUCTED VESSEL LUMEN BY PLACING A STENT OVER IT DURING THE STENT PHASE OF THE PROCEDURE. AS THE TIP REMNANT WAS POSITIONED WITHIN THE TARGET LESION, THERE WOULD HAVE BEEN NO ADDITIONAL STENT REQUIRED. PATIENT WAS NOT HARMED; PATIENT HAD CALCIFIED LAD CTO WHICH WAS SUCCESSFULLY TREATED. IT WAS REPORTED AS TORQUING TOO MUCH IN CALCIUM.

  Patient problems: Foreign Body Embolism

  MAUDE report 10525004 ↗
• InjuryAug 28, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A UNIT WAS USED DURING A CTO PCI STUDY. DURING A CTO PCI PROCEDURE ON THE STUDY SUBJECT IT IS REPORTED THAT THE TIP OF A TURNPIKE SPIRAL CATHETER BROKE OFF AND HAD TO BE STENTED TO THE WALL OF THE RCA. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED 24AUG2020: DURING A CTO PCI PROCEDURE IT IS REPORTED THAT THE TIP OF A TURNPIKE SPIRAL CATHETER BROKE OFF AND HAD TO BE STENTED TO THE WALL OF THE RCA. THE LESION WAS IN THE PROXIMAL RCA WITH A J-CTO SCORE OF GREATER THAN 3. THE LESION WAS 60 MM IN LENGTH WITH THE PRESENCE OF CALCIUM AND A > 45O BEND. 1-2 MM OF THE TUNGSTEN TIP OF THE TURNPIKE SPIRAL WAS VISIBLE IN THE RCA UNDER FLUOROSCOPY. RESULTED IN STENTING OF THE TIP TO THE VESSEL WALL. THIS PROCEDURE WAS ALSO COMPLICATED BY A PERFORATION OF THE DISTAL RCA THAT WAS TREATED WITH PROLONGED BALLOON INFLATION AND WAS DEEMED NOT RELATED TO THE USE OF THE STUDY DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 10466327 ↗