SiteSeer™ 4A0029Recalls & reported problems
Medtronic, Inc. · CATH 4A0029 SS 10PK 4F TRAD PG 145DG 110 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00613994894458), received between Nov 23, 2017 and Nov 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 23, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN USED A SITESEER CATHETER DURING THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE SITESEER CATHETER PACKAGING. THE CATHETER WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE CATHETER WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. THE DEVICE WAS USED IN THE AORTA, WHICH WAS NON-TORTUOUS AND NON- CALCIFIED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE PROCEDURE INVOLVED A RIGHT HEART CASE, AND A NON-MEDTRONIC WIRE WAS USED. RESISTANCE WAS ENCOUNTERED DURING DELIVERY TO THE TARGET LESION, WITH THE NON-MDT GUIDEWIRE INSERTED THROUGH THE LUMEN OF THE SITESEER CATHETER. RESISTANCE WAS FELT MANOEUVRING THE CATHETER IN VIVO, AND THE CATHETER KINKED. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT IN THE HOLDING ROOM WHEN THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT, THEY FOUND PART OF THE CATHETER WAS BROKEN. THE TIP OF THE SITESEER WAS FOUND IN THE INTRODUCER SHEATH. THE SHEATH WAS CUT OPEN BY THE PHYSICIAN TO REMOVE THE DETACHED TIP OF THE SITESEER CATHETER. THERE WAS NO RESISTANCE NOTED WHEN REMOVING THE NON-MEDTRONIC WIRE FROM THE CATHETER. THE CATHETER WAS NOT EXCESSIVELY TORQUED. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7057278 ↗
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
- TrapEase Permanent Vena Cava Filter with the VisEase Angiographic Vessel Dilator 466P306AUCordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 deaths186 reports
- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page