Leung G21520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002215207), received between May 2, 2019 and May 2, 2019 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2019Break; Break

  AS REPORTED TO CUSTOMER RELATIONS " THE INITIAL ERCP CANNULATION WAS PERFORMED. THE GUIDE WIRE WAS PASSED INTO THE COMMON BILE DUCT WITHOUT PROBLEMS. THE FIRST NASAL BILIARY DEVICE (B)(4) WAS FED OVER THE GUIDE WIRE (VISIGLIDE .025 - 450). THE TIP OF THE DEVICE BROKE (SEPARATED) WHILE FEEDING THE WIRE THROUGH. THIS OCCURRED OUTSIDE OF THE PATIENT AND SCOPE. THE DEVICE WAS REMOVED FROM THE WIRE AND SAVED TO SEND BACK TO THE MANUFACTURER. THE SECOND DEVICE (B)(4) WAS FED OVER THE GUIDE WIRE THROUGH THE SCOPE WITHOUT RESISTANCE AND WAS ADVANCED INTO THE COMMON BILE DUCT. THE GUIDE WIRE WAS REMOVED AND ASPIRATION BEGAN. WHEN THE GUIDE WIRE WAS ADVANCED BACK THROUGH THE CATHETER AND THE TUBE WAS EXTRACTED, A TWO INCH PIECE OF THE TIP REMAINED INSIDE THE PATIENT. ADDITIONAL ATTEMPTS TO REMOVE THE PIECE IN THE LIVER WAS DIFFICULT, RESULTING IN ADDITIONAL PROCEDURE TIME. A SPYGLASS DEVICE WAS INSERTED OVER THE WIRE TO RETRIEVE THE DISLODGED PIECE WITH SUCCESS. THE PROCEDURE WAS COMPLETED WITH A STANDARD BILIARY STENT." FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE REQUIREMENT FOR SURGICAL INTERVENTION IN ORDER TO REMOVE THE 2 INCH PIECE OF THE TIP FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8572620 ↗
• MalfunctionMay 2, 2019Break; Break

  AS REPORTED TO CUSTOMER RELATIONS " THE INITIAL ERCP CANNULATION WAS PERFORMED. THE GUIDE WIRE WAS PASSED INTO THE COMMON BILE DUCT WITHOUT PROBLEMS. THE FIRST NASAL BILIARY DEVICE (B)(4) WAS FED OVER THE GUIDE WIRE (VISIGLIDE .025 - 450). THE TIP OF THE DEVICE BROKE (SEPARATED) WHILE FEEDING THE WIRE THROUGH. THIS OCCURRED OUTSIDE OF THE PATIENT AND SCOPE. THE DEVICE WAS REMOVED FROM THE WIRE AND SAVED TO SEND BACK TO THE MANUFACTURER. THE SECOND DEVICE (B)(4) WAS FED OVER THE GUIDE WIRE THROUGH THE SCOPE WITHOUT RESISTANCE AND WAS ADVANCED INTO THE COMMON BILE DUCT. THE GUIDE WIRE WAS REMOVED AND ASPIRATION BEGAN. WHEN THE GUIDE WIRE WAS ADVANCED BACK THROUGH THE CATHETER AND THE TUBE WAS EXTRACTED, A TWO INCH PIECE OF THE TIP REMAINED INSIDE THE PATIENT. ADDITIONAL ATTEMPTS TO REMOVE THE PIECE IN THE LIVER WAS DIFFICULT, RESULTING IN ADDITIONAL PROCEDURE TIME. A SPYGLASS DEVICE WAS INSERTED OVER THE WIRE TO RETRIEVE THE DISLODGED PIECE WITH SUCCESS. THE PROCEDURE WAS COMPLETED WITH A STANDARD BILIARY STENT." FDA MDR REPORTING REQUIRED: REPORTING BASED ON THE DECISION FOR PR (B)(4) (SURGICAL INTERVENTION) AS THIS WILL ESTABLISH A PRECEDENCE FOR ENBD 'CATHETER FRACTURE/BREAKAGE'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8572610 ↗