Skater™ Biliary Drainage Catheter Locking Pigtail 10Fr x 40 cmRecalls & reported problems
Argon Medical Devices, Inc. · Skater™ Biliary Drainage Catheter Locking Pigtail with Radiopaque Band (10Fr x 40 cm) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333006137), received between Aug 22, 2023 and Sep 20, 2023 — classified as 2 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2023Break; Break
THE HOSPITAL USED A DRAINAGE TUBE TO COMPLETE BILIARY PUNCTURE AND DRAINAGE FOR THE PATIENT ON (B)(6) 2023. THE PATIENT WAS ABOUT TO WITHDRAW THE TUBE ON (B)(6), BUT DURING THE ANGIOGRAPHY, IT WAS FOUND THAT THE DRAINAGE TUBE WAS BROKEN IN TWO SECTIONS.
Patient problems: Insufficient Information
MAUDE report 17781402 ↗MalfunctionAug 22, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
ON AUGUST 3, 2022, A DRAINAGE TUBE DISCONNECTION INCIDENT OCCURRED AT LAIXI CITY PEOPLE'S HOSPITAL IN THE AREA. ACCORDING TO CLINICAL DESCRIPTION, THE DRAINAGE TUBE WAS NOT OPERATED DURING ITS RELEASE, AND WAS PLACED INSIDE THE STENT WITHOUT BEING CUT BY THE STENT. AFTER THE CATHETER WAS PLACED, STRICT SUTURE TREATMENT WAS PERFORMED. THE PATIENT WENT TO THE HOSPITAL FOR A WEEK AFTER THE CATHETER WAS PLACED, AND BEFORE THE CATHETER WAS REMOVED, IMAGING REVEALED THAT THE CONTRAST AGENT HAD LEAKED OUT OF THE BODY, RESULTING IN THE DISCONNECTION OF THE TUBE. IT WAS FOUND THAT THE CATHETER WAS BROKEN IN THE BODY, AFTER REMOVING THE FIRST HALF, OBSERVATION WAS ALSO CONDUCTED, AND IT WAS CLINICALLY DETERMINED THAT THE DRAINAGE TUBE IS A SPLIT TYPE.
Patient problems: Insufficient Information
MAUDE report 17595821 ↗
Other Catheter, Biliary, Diagnostic devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 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 18, 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