Journey™ M001391280Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729789840), received between Dec 14, 2017 and May 29, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 300CM JOURNEY GUIDE WIRE WAS SELECTED FOR USE WITH A MICROCATHETER IN AN EMBOLIZATION PROCEDURE TO TREAT A VARICOCELE. HOWEVER, IT WAS NOTED THAT CONTRAST COULD NOT BE INJECTED INTO THE MICROCATHETER AS IT APPEARED TO BE BLOCKED. THE TIP OF THE JOURNEY WIRE WAS NOTED TO BE DAMAGED. UPON USING THE BACKEND OF THE WIRE TO CLEAR THE MICROCATHETER, IT WAS NOTED THAT THE TIP OF THE WIRE WAS EMBEDDED INTO THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LOCATION WAS LOCATED IN THE MILDLY TORTUOUS GONADAL VEIN VARICOCELE. THE DETACHED TIP BECAME LODGED IN THE MICROCATHETER THROUGH THE MID SEGMENT. THE PHYSICIAN REMOVED THE DETACHED TIP FROM THE PATIENT BY REMOVING THE MICROCATHETER AND WIRE. THE INTERVENTION WAS THEN PERFORMED WITH A NON BSC GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650582 ↗
• InjuryFeb 20, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY. A 300CM JOURNEY GUIDEWIRE WAS ADVANCED TO THE DORSALIS PEDIS ARTERY; HOWEVER, THE DEVICE WAS NOT ABLE TO ENTER THE LESION. DURING RETRIEVAL, THE WIRE WAS CAUGHT BY THE HEAVY CALCIFICATION AND WAS DISCONNECTED BY 30CM FROM THE TIP. THE PATIENT WAS IN GOOD CONDITION WITHOUT FURTHER COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. SURGERY WAS ARRANGED AND THE WIRE WAS REMOVED SURGICALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354613 ↗
• MalfunctionFeb 13, 2019Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT REMOVING DIFFICULTY OCCURED. A TARGET LESION WAS LOCATED AT ANTERIOR TIBIAL ARTERY. A 300CM 1 PK JOURNEY GUIDEWIRE WAS ADVANCE, BUT FAILED TO CROSS THE LESION. HOWEVER, THE JOURNEY GUIDE WIRE WAS PLACED TO THE DOSALIS PEDIS ARTERY DURING THE PROCEDURE, THE WIRE WAS NOT ABLE TO ENTER THE LESION ANYMORE, AND THE WIRE WAS CAUGHT BY A HEAVY CALCIFIED LESION DURING THE WIRE RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH SAME USE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8337270 ↗
• InjuryJan 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 300CM JOURNEY GUIDE WIRE WAS ADVANCED WITHIN THE LEFT ANTERIOR TIBIAL ARTERY. IT WAS OBSERVED THAT THE TIP OF THE JOURNEY WIRE DETACHED WITHIN THE LEFT ANTERIOR TIBIAL ARTERY. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED VIA A RETRIEVAL DEVICE, ONCE THE DETACHED TIP WAS WITHIN THE SHEATH THE PHYSICIAN USED A BODY WIRE NEXT TO THE RETRIEVAL DEVICE AND INFLATED A 6MM BALLOON INSIDE THE SHEATH TO TRAP IT INSIDE THE SHEATH AND EVERYTHING WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210183 ↗
• MalfunctionDec 14, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR ID# 2134265-2017-12413. IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TOURTOUS AND MILDLY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6F NON BSC INTRODUCER SHEATH WAS ADVANCED TO THE RIGHT COMMON FEMORAL ARTERY (CFA) WITHOUT DIFFICULTY BY LEFT BRACHIAL APPROACH. THERE WAS NO PARTICULAR SEVERE TORTUOSITY IN THE LEFT SUBCLAVIAN, AORTA, EXTERNAL ILIAC ARTERY AND SFA. PRE DILATATION WAS PERFORMED USING A 6.0X100 NON BSC BALLOON CATHETER. SUBSEQUENTLY A 6.0X200 NON BSC STENT WAS PLACED IN DISTAL SFA. A 7X150X130 INNOVA STENT DELIVERY SYSTEM WAS THEN ADVANCED OVER A 300CM JOURNEY GUIDEWIRE TO THE TARGET LESION WITHOUT RESISTANCE. THERE WAS NO STEEP TORTUOSITY AND CALCIFICATION NOTED. STENT DEPLOYMENT WAS THEN INITIATED. DEPLOYMENT OF THE STENT STARTED SMOOTHLY THEN ABOUT HALFWAY FROM RELEASING, THE FORCE THAT ROTATES THE THUMBWHEEL BECAME GRADUALLY HARDER. ABOUT 5CM WAS NOT RELEASED EVEN AFTER FULLY DEPLOYING THE THUMBWHEEL AND PULL GRIP. THE PHYSICIAN THEN PULLED BACK THE ENTIRE DELIVERY SYSTEM, IT WAS NOTED THAT THE 300CM JOURNEY GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE INNOVA STENT DELIVERY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7118111 ↗