OffRoad™ H74939202100540Recalls & reported problems
Boston Scientific Corporation · Re-Entry Catheter System · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729798729), received between Apr 3, 2019 and Apr 3, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14MAR2019. IT WAS REPORTED THAT THE DEVICE WAS KINKED AND HAD DIFFICULTY ADVANCING. THE TARGET LESION WAS LOCATED IN SUPERIOR FEMORAL ARTERY. AN OFFROAD WAS SELECTED FOR USE. DURING THE PROCEDURE, THE RE-ENTRY LOCATION WAS IDENTIFIED AND THE BALLOON WAS POSITIONED WITHIN THE DISTAL PART OF THE LESION. THE BALLOON WAS INFLATED TO TWO AND A HALF ATMOSPHERES. SUBSEQUENTLY, THE ZIPWIRE WAS REMOVED FROM THE POSTIONING BALLOON AND REPLACES WITH A THRUWAY GUIDEWIRE. IT WAS DIFFICULT TO ADVANCE THE MICROLANCET OVER THE WIRE INSIDE THE BALLOON CATHETER AND BECAME SIGNIFICANTLY KINKED. THE MICROLANCET FAILED TO ADVANCE FURTHER. THE DEVICES WERE REMOVED. THE PROCEDURE WAS NOT COMPLETED AS RE-ENTRY OF THE LESION WAS UNABLE TO OCCUR. NO PATIENT COMPLICATIONS WERE REPORTED. ANOTHER ATTEMPT TO CROSS THE TOTAL OCCLUSION WAS TO BE PLANNED IN THE FUTURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS BROKEN 40CM DISTAL FROM THE HUB. IT WAS FURTHER REPORTED THAT THE BREAK LIKELY OCCURRED DURING THE PROCEDURE WHEN THE LANCET WOULD NOT ADVANCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8478294 ↗
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- OUTBACK OTB59120ACordis US Corp. · Catheter for crossing total occlusions82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.