Skater™ Biliary Drainage Catheter Locking Pigtail 8Fr x 40 cmRecalls & reported problems
Argon Medical Devices, Inc. · Skater™ Biliary Drainage Catheter Locking Pigtail with Radiopaque Band (8Fr x 40 cm) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886333006113), received between Feb 3, 2021 and Jun 18, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Defective Device1
- Detachment of Device or Device Component1
- Material Fragmentation1
Patient problems
- Insufficient Information2
- Malaise1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Break; Break
THREE DAYS AFTER PLACEMENT, THE DRAINAGE TUBE BROKE AND WAS SURGICALLY REMOVED.
Patient problems: Insufficient Information
MAUDE report 22287904 ↗MalfunctionAug 4, 2022Defective Device; Detachment of Device or Device Component
THE PROCEDURE WAS STARTED WITH ULTRASOUND-GUIDED FINE NEEDLE PUNCTURES. AMPLATZ GUIDE WIRE IS INSERTED. AFTER DILATION WITH A BALLOON CATHETER, PTC CATHETERS ARE INSERTED. WHEN THE GUIDE WIRE IS TO BE REMOVED FROM THE RIGHT PTC DRAIN, IT IS NOTED THAT THE DRAIN HOSE HAS COME OFF (IN WHAT APPEARS TO BE A MANUFACTURING DEFECT) AT THE HEIGHT OF THE X-RAY-TIGHT MARKING. HOWEVER, THE STRINGS TO THE STRING LOCK ARE STILL INTACT. TRYING TO REMOVE THE STRINGS, AND LEAVE THE REMAINING CATHETER IN THE INTESTINE, BUT THESE ARE STUCK AND THE CATHETER BACKS UP NICELY AGAINST THE PUNCTURE HOLE. THE CATHETER GETS STUCK,SUBCUTANEOUSLY. I MAKE A SHORT INCISION IN THE SKIN AND WITH MOSQUITO DEBRIS DOWN UNTIL THE CATHETER IS VISUALIZED AFTER WHICH IT CAN BE EXTRACTED.
Patient problems: Insufficient Information
MAUDE report 15168498 ↗MalfunctionMar 15, 2022Break
THE PATIENT HAD BEEN INTUBATED FOR 4 DAYS, AND THE DRAINAGE TUBE BROKE WHEN IT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13767385 ↗MalfunctionFeb 3, 2021Material Fragmentation
THE PATIENT WAS MONITORED BECAUSE HE WAS NOT FEELING WELL, AND IT WAS OBSERVED IN THE ANGIOGRAPHIC CONTROL THAT THE CATHETER HAD FRAGMENTED JUST IN THE AREA OF THE RADIOPAQUE MARK.
Patient problems: Malaise
MAUDE report 11276547 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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