Advance G34993Recalls & reported problems
Cook Incorporated · Advance, Salivary Balloon Catheter · Class 2
All models of Advance (206)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002349930), received between Oct 4, 2017 and Oct 4, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Code Available1
- 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.
InjuryOct 4, 2017Break; Break
THE AREA REPRESENTATIVE REPORTED DURING A SIALOENDOSCOPY PROCEDURE, THE GUIDEWIRE THAT CAME PACKAGED WITH THE ADVANCE SALIVARY BALLOON CATHETER BROKE IN HALF. THE GUIDE WIRE WAS IN THE CHANNEL OF THE ADVANCE BALLOON. WHEN THE DOCTOR REMOVED THE BALLOON TO ASSESS THE DILATION, IT WAS NOTICED THE GUIDE WIRE WAS BROKEN. THE SOLID PORTION OF THE GUIDE WIRE WAS FULLY INSIDE THE BALLOON WHEN REMOVED. AS REPORTED, THEY WERE NOT SURE EXACTLY WHEN IT BROKE, BUT NOTICED IT WHEN WITHDRAWING THE BALLOON. THERE WAS NO NOISE AND THE BALLOON STILL FUNCTIONED AFTER THE GUIDE WIRE BROKE. THE GUIDEWIRE WAS BROKEN AT A FUSE POINT BETWEEN THE 2 SEGMENTS OF THE WIRE WHERE THE SOLID GUIDE WIRE BECOMES FLEXIBLE. THE DISTAL PART OF THE WIRE (FLEXIBLE PORTION) HAD ABOUT 1.5 INCHES EXTENDING OUT OF THE PATIENT¿S DUCT. THE DOCTOR SIMPLY GRABBED THE PORTION OUTSIDE OF THE DUCT AND REMOVED IT. THE GUIDEWIRE WAS WITHDRAWN AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THERE WERE NO ADDITIONAL PROCEDURES REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL PATIEN
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 6914210 ↗
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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.
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