TRAPLINER IPN914358Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10841156102135), received between Sep 5, 2019 and Feb 2, 2023 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT,"BALLOON RUPTURED AT 12 ATM. 7F GUIDE EXTENSION (TRAPLINER) BROKE OFF WHEN TRYING TO REMOVE FROM GUIDE CATHETER." ADDITIONAL INFORMATION WAS REPORTED ON (B)(6) 2023: PROCEDURE WAS A HIGH-RISK PCI TO THE LAD WITH THE LESION IN THE PROXIMAL LAD. THE VESSEL WAS CALCIFIED AND NOT TORTUOUS. NO BALLOON FRAGMENTS WERE NOTED TO BE SEPARATED AFTER IT BURST. THE TRAPLINER WAS BROKEN BETWEEN THE HALF PIPE AND THE BALLOON. INCIDENT OCCURRED INSIDE THE BODY. PART OF THE TRAPLINER WAS PULLED OUT COMPLETELY WITH GUIDE CATHETER. THE PHYSICIAN HAD TO DISSECT THE GUIDING CATHETER TO FIND THE BROKEN GUIDE EXTENSION BEFORE PROCEEDING WITH INTERVENTION. NO PATIENT HARM NOTED. EVERYTHING WAS COMPLETELY REMOVED. THE PHYSICIAN USED AN OTW BALLOON FOR TRAPPING TECHNIQUE AND AN ATHERECTOMY DEVICE TO COMPLETE THE PROCEDURE. PATIENT'S CURRENT CONDITION WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283173 ↗
• MalfunctionAug 4, 2022Material Integrity Problem; Material Integrity Problem

  AS REPORTED: TRAPLINER WAS DEFECTIVE DURING A RECENT PROCEDURE. ACCORDING TO CLINICAL, IT DETACHED DURING THE PROCEDURE. SEVERAL GOOD FAITH ATTEMPTS HAVE BEEN MADE TO RECEIVE ADDITIONAL INFORMATION REGARDING HOW THE TRAPLINER DETACHED AND PATIENT CONDITION WITH NO RESPONSE FROM HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 15171074 ↗
• MalfunctionJun 7, 2022Material Separation; Material Separation

  AS REPORTED, USED A CATHETER ONCE AND THEN REMOVED FROM THE PATIENT'S BODY. WHEN THERE WAS A SECOND ROUND TO INSERT THE CATHETER INTO THE PATIENT IT FELL APART AT THE ENTRANCE TO THE SHEATH. ADDITIONAL INFORMATION RECEIVED STATED CATHETER DID NOT FALL APART WITHIN THE PATIENT'S BODY BUT IT FELL APART INTO THE SHEATH. THE DOCTOR REMOVED FROM THE SHEATH USED A NEW CATHETER AND THE SECONDARY DEVICE WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621451 ↗
• MalfunctionJan 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: TRAPLINER WAS INSERTED. UPON INFLATION OF THE BALLOON BLOOD COMING BACK INTO INFLATION SYRINGE. PROVIDERS ASSUMED BALLOON WAS RUPTURED. AFTER IT WAS REMOVED IT WAS NOTED THAT THE HYPO-TUBE SEPARATED AT THE TIP OF THE CATHETER. UPON INSPECTION OF THE DEVICE, IT APPEARS THE HYPO-TUBE WAS DAMAGED EITHER FROM MANUFACTURER, OR UPON REMOVAL OF PACKAGING, OR DURING INSERTION THROUGH GUIDE CATHETER. IT IS UNKNOWN WHEN IT WAS DAMAGED. NO PATIENT HARM. SUCCESSFUL CASE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175137 ↗
• MalfunctionAug 31, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: CATHETER CAME APART DURING A CASE - BALLOON FAILED TO INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392266 ↗
• MalfunctionJul 20, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: TRAPLINER 7F SHAFT BROKE IN LAD / LCX IN PULLBACK POSITION , TRAPLINER BALLOON NPR 12 BAR NO PROBLEM. TRAPLINER BROKE OUT OF THE PATIENT'S BODY, IT WAS IN PULLBACK POSITION. NO PARTS WERE LEFT IN THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200255 ↗
• MalfunctionJul 20, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: THE TRAPLINER CATHETER BROKE AT THE TIME OF REMOVAL FROM CATHETER GUIDE. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200249 ↗
• MalfunctionMar 17, 2021Separation Problem; Separation Problem

  AS REPORTED: TRAPLINER BROKE AT HYPO TUBE BEFORE HALFPIPE UPON ENTERING INTO GUIDE CATHETER. COMPLETED WITH A DIFFERENT DEVICE. CURRENT PATIENT CODITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506242 ↗
• MalfunctionNov 16, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: TRAPLINER BROKE AT, OR NEAR WELD POINT DURING THE PROCEDURE. DEVICE WAS REMOVED FROM THE PATIENT WITH NO ISSUES. PULLED OUT MANUALLY, WAS ABLE TO INFLATE A CORONARY BALLOON PAST THE FRACTURED PIECE, AND PULLED IT BACK THROUGH THE GUIDE CATHETER, AND OUT OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10842972 ↗
• MalfunctionOct 29, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: WHEN OPENING THE STERILE PACKAGING, THE INTERVENTIONAL CARDIOLOGIST DISCOVERED A DEFECT AT THE TRAPLINER AT THE CONNECTION BETWEEN PUSHROD AND THE HALFPIPE. IT WAS ALMOST COMPLETELY BROKEN. AS A RESULT, THEY COULD NOT USE THE PRODUCT AND THEY HAD TO USE A NEW ONE. CORRECTED INFORMATION RECEIVED 11 AUG 2020: AFTER THE USE OF THE TRAPLINER IN THE PATIENT, THE INTERVENTIONAL CARDIOLOGIST WANTED TO WITHDRAW THE TRAPLINER OUT OF THE CORONARY ARTERY. BECAUSE OF THE TORTUOSITY OF THE CORONARY ARTERY HE EXPERIENCED A LOT OF FRICTION WHEN HE TRIED TO DO THIS. AT A CERTAIN MOMENT THE PUSHROD BECAME TOTALLY LOOSE FROM THE GUIDE EXTENSION. FORTUNATELY, THIS HAPPENED WHEN THE GUIDE EXTENSION JUST CAME OUT OF THE BLOOD VALVE, SO THE CARDIOLOGIST WAS ABLE TO TAKE THIS PART OUT OF THE VALVE WITH HIS HANDS. TO BE CLEAR, THERE WAS NOTHING WRONG WITH THE DEVICE PRIOR TO GIVING IT TO THE CARDIOLOGIST; IT WAS INSPECTED BEFORE HANDING OVER TO HIM. PROBLEM OCCURRED WHEN PULLING BACK THE DEVICE AFTER USING IT. NO MEDICAL INTERVENTION WAS PERFORMED. THE PACKAGING WAS NOT DAMAGED PRIOR TO OPENING THE STERILE POUCH. MULTIPLE ATTEMPTS WERE MADE TO RETURN THE DEVICE FOR INVESTIGATION AND CLARIFICA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10754686 ↗
• InjuryAug 28, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT THERE WAS VERY, LONG AND COMPLICATED CASE (CTO) AND THEY USED A LOT OF DEVICES. THEY USED TRAPLINER AND IT BROKE OFF IN THE PLACE OF SHAFT AND HALF-PIPE PART. THEY TOOK OUT THE TRAPLINER WITH A MICROCATHETER AND USED NEW TRAPLINER AND CONTINUED. THE PREPARATION WAS OK, DOCTOR IS VERY EXPERIENCED, AND A SECOND TRAPLINER HELPED. THE PATIENT WAS NOT INJURED. CTO SUCCESSFULLY COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10465277 ↗
• MalfunctionJul 10, 2020Device Damaged by Another Device; Separation Problem; Device Damaged by Another Device; Separation Problem

  AN EMAIL RECEIVED FROM THE CUSTOMER REPORTED THAT THEY HAD A CASE WHERE THEY HAD A STENT CATCH ON THE TRAPLINER AND THE SHAFT BROKE AWAY FROM THE TUBING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10257704 ↗
• InjuryNov 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  TRAPLINER BROKE AT TRANSITION POINT WHILE IT WAS BEING ADVANCED INTO THE GUIDE CATHETER, PHYSICIAN REMOVED THE TRAPLINER. COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY OR IMPACT REPORTED. THE DEVICE WAS REPORTED AS DISCARDED AT THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9328132 ↗
• MalfunctionSep 5, 2019Material Puncture/Hole; Material Puncture/Hole

  THE CASE WAS A CTO/ISR IN AN RCA, NO TORTUOSITY. WHEN TRYING TO REMOVE A BALLOON, IT BECAME STUCK IN TRAPLINER. PHYSICIAN REMOVED TRAPLINER AND NOTICED THE TRAPLINER HAD ACCORDIONED, AND HE ALSO SAW A HOLE. AN ORBITAL ATHERECTOMY DEVICE WAS USED TO FRACTURE THE STENT WHILE THE TRAPLINER WAS IN AND MULTIPLE BALLOONS WERE PASSED THROUGH THE TRAPLINER. THIS EVENT OCCURRED AT THE END OF THE CASE, SO THEY DID SOME FINAL BALLOON INFLATIONS TO COMPLETE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8965130 ↗