TRAPLINER IPN914357Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10841156102128), received between Nov 13, 2019 and Jul 15, 2024 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT: " HYPO TUBE PUSH ROD GOT DETACHED FROM HALF PIPE. MEDICAL PROCEDURE WAS BEING PERFORMED WAS " PERCUTANEOUS TRANSFEMORAL CORONARY ANGIOPLASTY" DEVICE REMOVED ENTIRELY AND TREATMENT GOT DELAYED DUE TO THIS DEFECT." ADDITIONAL INFORMATION: THE ISSUE OCCURRED AT THE END OF THE PROCEDURE WHICH WAS VIA THE RCA. THE LESION WAS AT THE PROXIMAL END OF THE RCA & DISTAL RCA. THE PROCEDURE WAS COMPLETED BUT THE DEVICE WAS DAMAGED DURING EXTRACTION. THE DEVICE WAS REMOVED ENTIRELY, AND TREATMENT GOT DELAYED DUE TO THIS DEFECT. THE PATIENT WAS REPORTED AS FINE WIT REPORTED HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738338 ↗
• MalfunctionJul 11, 2022Material Separation; Material Separation

  AS REPORTED: ADVANCED TRAPLINER THROUGH HEMOSTATIC VALVE AND TRAPLINER SNAPPED/BROKE OFF. RETRIEVED FROM THE PATIENT BY PULLING BACK; NO SNARE USED. NO HARM TO PATIENT FROM AS PULLED OUT AT BEGINNING WHEN ADVANCING IN HEMOSTATIC VALVE. LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983341 ↗
• MalfunctionAug 31, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: CATHETER BROKE PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392241 ↗
• MalfunctionApr 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS REPORTED: AS REPORTED: CTO OF RCA. TRAPLINER USED IN ANTEGRADE 6FR. GUIDE CATHETER. HIGH RESISTANCE WAS FELT TO MOVE THE CATHETER AND OTHER MICROCATHETERS. FOUND 2 CYCLES OF WIRE WRAP. CORRECTION OF WRAP DID NOT RESOLVE THE PROBLEM WITH THE HIGH RESISTANCE. WHEN TRAPLINER WAS REMOVED, THERE WAS SEPARATION OF THE HALF PIPE FROM THE RIBBON WIRE PUSH ROD. IT IS UNKNOWN IF THIS WAS CAUSED BY THE HIGH TENSION WITHIN THE SYSTEM. TRAPLINER WAS NEVER MORE THAN 5CM OUTSIDE OF THE GUIDE CATHETER THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638152 ↗
• MalfunctionOct 15, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: RAILING POLYMER DETACHED, AND BALLOON POPPED. UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10687034 ↗
• MalfunctionOct 13, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED: TRAPLINER PUSH ROD COMPLETELY PULLED OFF OF THE HALF-PIPE. PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS OTHER THAN TIME, NO ADJUNCT INTERVENTION WAS NECESSARY. THE PROCEDURE WAS A CTO OF RCA WITH A LOT OF CALCIUM AND LONG LESION; NEEDED A LOT OF FORCE TO DELIVER THE TRAPLINER DISTALLY IN THE VESSEL. PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS ANOTHER TRAPLINER WAS USED. THE EXTENSION SEGMENTS BROKE OFF IN THE GUIDE CATHETER AND WERE REMOVED BY HAND. ASSOCIATED TO MDR 2134812-2020-00067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10673740 ↗
• MalfunctionOct 13, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  HOLD FOR R.G 1.20AS REPORTED: TRAPLINE PUSH ROD COMPLETELY PULLED OFF OF THE HALF-PIPE. PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS OTHER THAN TIME, NO ADJUNCT INTERVENTION WAS NECESSARY. THE PROCEDURE WAS A CTO OF RCA WITH A LOT OF CALCIUM AND LONG LESION; NEEDED A LOT OF FORCE TO DELIVER THE TRAPLINER DISTALLY IN THE VESSEL. PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS ANOTHER TRAPLINER WAS USED. THE EXTENSION SEGMENTS BROKE OFF IN THE GUIDE CATHETER AND WERE REMOVED BY HAND. ASSOCIATED TO MDR 2134812-2020-00068

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10673621 ↗
• MalfunctionOct 12, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  HOLD FOR R.G. 1.20AS REPORTED: PHYSICIAN STATED THE TIP BROKE OFF WHEN REMOVING THE TRAPLINER FROM THE PATIENT AT THE END OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10667809 ↗
• MalfunctionSep 10, 2020Separation Problem; Separation Problem

  AS REPORTED: TIP BROKE OFF BEING INSERTED INTO PATIENT. USED ANOTHER DEVICES WITH NO ISSUES. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10514294 ↗
• InjuryJul 8, 2020Fracture; Fracture

  REPORTED AS A SHAFT SEPARATION: STUDY # 009-02. WHEN REMOVING THE 6FR TRAPLINER FROM THE PATIENT IN A HIGHLY COMPLEX MORPHOLOGY OF THE VESSEL, THE CATHETER SEPARATED. WE RETRIEVED THE PIECE WITH A SNARE DEVICE. AFTER THE PIECE WAS REMOVED, THE PROCEDURE WAS COMPLETED AS PLANNED. A FRAGMENT OF THE CATHETER WITH A MARKER BAND WAS MISSING. THE ACCOUNT STATED THAT NO PART OF THE CATHETER WAS LEFT BEHIND IN THE PATIENT. THERE WERE NO COMPLICATIONS TO THE PATIENT. THE PATIENT STAYED OVERNIGHT (PER STANDARD OF CARE) AND DISCHARGED TO HOME THE NEXT DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10246047 ↗
• MalfunctionApr 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS ADVANCING THE TRAPLINER, THE FLUSH PORTION COMPLETELY CAME OFF THE SHAFT. NO FURTHER COMPLICATIONS WERE REPORTED. ASSOCIATED TO MDR 2134812-2020-00031 TRAPLINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9943224 ↗
• MalfunctionApr 8, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TRAPLINER SNAPPED WHILE NOT UNDER ANY PRESSURE WITH THE PHYSICIAN. NO FURTHER COMPLICATIONS WERE REPORTED. MULTIPLE ATTEMPTS WERE MADE TO RECEIVE ADDITIONAL INFORMATION BUT WERE UNSUCCESSFUL. ASSOCIATED TO MDR 2134812-2020-00032 TRAPLINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9939270 ↗
• MalfunctionJan 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TRAPLINER HAD BEEN BACKLOADED OVER THE GUIDEWIRE AND WAS GOING TO BE ADVANCED INTO THE VALVE WHEN IT BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9653871 ↗
• MalfunctionJan 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE SCRUB TECH OPENED THE PACKAGE, THE TRAPLINER TIP WAS BROKEN OFF AND THEY DID NOT USE THE PRODUCT. IT WAS NOTED THAT A NEW DEVICE WAS OPENED AND WAS FINE. NO PATIENT WAS INVOLVED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9653761 ↗
• MalfunctionDec 23, 2019Solder Joint Fracture; Detachment of Device or Device Component; Solder Joint Fracture; Detachment of Device or Device Component

  AS REPORTED: THE TRAPLINER SHAFT BROKE DURING INSERTION IN A CTO CASE OF THE RCA. ADDITIONAL INFORMATION RECEIVED 17DEC19 THERE WAS NO RESISTANCE FELT HOWEVER, THE VESSEL WAS CALCIFIED. THE TRAPLINER RETRIEVED AFTER INSERTION, IT CAME OUT MANUALLY WITHOUT DIFFICULTY. PATIENT OUTCOME IS REPORTED AS FINE, WITH A SUCCESSFUL FIX OF THE RCA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9512228 ↗
• MalfunctionNov 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  COMPLEX PCI OF THE RCA. DIFFICULTY ENGAGING A 6FR GUIDE CATHETER. ONCE ENGAGED USED 6FR TRAPLINER FOR ADDED SUPPORT, BUT MINIMAL EXTENSION WAS OUTSIDE OF THE GUIDE CATHETER. WE WERE UNSUCCESSFUL IN GETTING MICROCATHETER PAST LESION SO REMOVED TRAPLINER IN ORDER TO USE A ROTATIONAL ATHERECTOMY SYSTEM. TRAPLINER WAS THEN REINSERTED AND RESISTANCE WAS FELT IN THE LAST 10CM OF THE MICROCATHETER, BUT THERE WERE NO ISSUES WITH CONTINUING. THE TRAPLINER BALLOON WAS THEN INFLATED TO TRAP THE WIRE AND IN ORDER TO TRAP IN THE CATHETER, HOWEVER, THE BALLOON WOULDN'T INFLATE. ALL TRAPLINER BALLOON INFLATIONS WERE DONE AT 14ATM. IT WAS DETERMINED THAT THE TRAPLINER NEEDED TO BE REMOVED TO REPLACE WITH A 6FR GUIDELINER. DURING REMOVAL OF THE TRAPLINER OUTSIDE OF THE PATIENT, THE TRAPLINER GUIDE EXTENSION SEPARATED FROM THE HYPO-TUBE IN THE HEMOSTASIS VALVE. NO INJURY OR IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9315640 ↗