TRAPLINER IPN914359Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10841156102142), received between Dec 20, 2019 and Dec 19, 2023 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: SMALL MARKER AT TIP OF CATHETER CAME OFF IN A HEAVILY CALCIFIED RCA. DR WAS ABLE TO INFLATE A BALLOON DISTAL TO IT AND DRAG THE PIECE OUT AND DOWN INTO THE SHEATH. HE HAD TO LOSE ACCESS, CUT THE SHEATH AND REMOVE THE PIECE WITH THE BALLOONED INFLATED ALONG WITH THE REST OF THE TRAPLINER. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18354032 ↗
• InjuryFeb 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CARDIOLOGIST WAS PERFORMING A COMPLEX CTO TO THE LAD. THE TRAPLINER WAS USED. THERE WAS RETROGRADE AND ANTEGRADE ACCESS VIA RIGHT RADIAL. MICRO-CATHETERS AND GUIDEWIRES WERE USED IN THE VESSEL. AN INTRAVASCULAR ULTRASOUND (IVUS) ATTEMPT WAS UNSUCCESSFUL - UNABLE TO PROGRESS THROUGH CATHETER IS AREA OF SUBCLAVIAN. THE GUIDEWIRES WERE STUCK IN THE CATHETER. WHEN THE TRAPLINER WAS REMOVED, A SPLIT WAS IDENTIFIED ON THE CATHETER. ADDITIONAL INFORMATION ON 23FEB2023: THE ACCOUNT REPORTED THAT THERE WAS MULTIPLE 0.014" GUIDEWIRES IN THE TRAPLINER CATHETER. A 135CM MICROCATHETER WAS ALSO USED DURING THE PROCEDURE. GUIDEWIRE ACCESS WAS EVENTUALLY LOST DURING THE PROCEDURE. THE TRAPLINER WAS REMOVED IN ITS ENTIRETY, AND NO FRAGMENTS WERE LEFT IN THE VESSEL. IT WAS REPORTED THAT THE PERFORATION OCCURRED IN THE DISTAL LAD AND WAS TREATED WITH 2X2MM COILS. THERE WAS NO REPORT OF SIGNIFICANT BLOOD LOSS, AND THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. IT WAS REPORTED THAT THE PATIENT RECEIVED ADDITIONAL HOSPITALIZATION/MEDICAL CARE DUE TO THIS EVENT. THE CTO WAS ABORTED DUE TO THE PERFORATION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 16440043 ↗
• MalfunctionOct 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT: CUSTOMER STATED THAT THE UNIT WAS NOTICED TO BE DEFECTIVE BEFORE IT WAS TO BE LOADED INTO THE HEMOSTASIS VALVE. ADDITIONAL INFORMATION: DURING A CORONARY INTERVENTION, THE DEVICE DID NOT PAST THE HEMOSTASIS VALVE AND NEVER ENTERED THE PATIENT. THE DEVICE BROKE IN 2 PIECES DURING A CORONARY INTERVENTION. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15603716 ↗
• 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 2134812-2021-00020 TURNPIKE LP.

  Patient problems: Atrial Fibrillation

  MAUDE report 11457166 ↗
• MalfunctionFeb 17, 2021Separation Problem; Separation Problem

  AS REPORTED: WHILE TRYING TO ADVANCE AND RETRIEVE THE TRAPLINER THROUGH THE 8F INSIDE A GUIDE CATHETER TO ALLOCATE THE TIP INTO THE RIGHT RCA (RIGHT CORONARY ARTERY), IT SUDDENLY BROKE AND DISCONNECTED. THETRAPLINER WAS RETRIEVED IN THE GUIDE CATHETER AND THE PROCEDURE WENT ON WITHOUT TRAPLINER. PATIENT OUTCOME IS REPORTED AS WELL, WITH NO PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340661 ↗
• MalfunctionSep 23, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: DURING THE PROCEDURE A TRAPLINER 8FR WAS USED AND GOT CAUGHT ON THE WATCHDOG/COPILOT AND SPLIT APART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT DISCHARGED TO HOME WITH NO SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10577181 ↗
• MalfunctionAug 28, 2020Separation Problem; Separation Problem

  IT WAS REPORTED: A 8FR TRAPLINER DEVICE WAS USED DURING A CTO PCI STUDY CASE. DURING A CTO PCI PROCEDURE ON THE STUDY SUBJECT IT IS REPORTED THAT THE BALLOON OF AN 8F TRAPLINER "BLEW APART". NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED 24AUG2020: AT THE BALLOON OF AN 8F TRAPLINER "BLEW APART." THE LESION WAS LOCATED IN THE PROXIMAL RCA, HAD A J-CTO SCORE OF 1, THERE WAS NO CALCIUM OR TORTUOSITY PRESENT, LESION LENGTH WAS 40 MM. THE CASE WAS SUCCESSFUL WITH TIMI SCORE AT THE BEGINNING OF THE CASE OF 0 AND AT THE END OF THE CASE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT IT WAS NOTED THAT THE BALLOON HAD RUPTURED AND LOOKED LIKE IT HAD SEPARATED. IT IS UNKNOWN WHEN THE RUPTURE HAPPENED DURING THE CASE. THE DEVICE WAS DISPOSED OF AT THE END OF THE CASE AND WAS NOT RETRIEVED. AN 8FR GUIDECATHETER WAS USED. NO PART OF THE DEVICE WAS NOTED TO BE LEFT IN THE PATIENT. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO SEQUELAE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10465430 ↗
• MalfunctionDec 20, 2019Solder Joint Fracture; Detachment of Device or Device Component; Solder Joint Fracture; Detachment of Device or Device Component

  TRAPLINER BROKE AT THE TRANSITION POINT BETWEEN THE HYPO-TUBE AND HALFPIPE. NO INJURY OR IMPACT REPORTED. ADDITIONAL INFORMATION RECEIVED 19DEC19: THE DEVICE BROKE PUTTING INTO THE HEMOSTASIS VALVE AND WAS ABLE TO BE PULLED OUT BY HAND. THERE WAS NO RESISTANCE FELT DURING A CALCIFIED CTO OF RCA THAT HAD MINIMAL TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9503663 ↗