Quantum TTC G22657Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002226579), received between May 24, 2016 and Sep 23, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 3, 2023Open, Classified

   Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

   Z-0457-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND INFLATED THE BALLOON, BUT THE BALLOON WAS NOT INFLATED AS EXPECTED. THE USER RETRACTED THE DEVICE FROM PATIENT AND FOUND OUT THAT THE BALLOON WAS BROKEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106142 ↗
• MalfunctionFeb 25, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  DURING A DUODENAL PAPILLARY DILATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE BALLOON BURST DURING USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367923 ↗
• MalfunctionJul 3, 2018Hole In Material; Use of Device Problem; Hole In Material; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. DURING THE PROCEDURE, AFTER THE OPERATOR ADVANCED THE BALLOON ALONG THE WIRE GUIDE, [THEY] REACHED [THE] MAJOR DUODENAL PAPILLA. THEN, THE OPERATOR FOUND THE BALLOON COULD NOT BE INFLATED AFTER THEY INJECTED THE CONTRAST MEDIUM. THE DEVICE [FAILED TO DILATE]. THEN, THE OPERATOR WITHDREW THE DEVICE AND INFLATED IT WITH AIR, AND PUT IT INTO THE WATER AND FOUND THERE WERE TWO SMALL HOLES AT THE BALLOON. THEN, THE OPERATOR REPLACED IT WITH ANOTHER OF THE SAME TYPE OF DEVICE TO FINISH THE PROCEDURE SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660826 ↗
• MalfunctionNov 22, 2017Hole In Material; Leak/Splash; Off-Label Use; Hole In Material; Leak/Splash; Off-Label Use

  DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) [OFF-LABEL USE], THE BALLOON WAS INFLATED AND THE USER NOTED THAT THERE WAS A PINHOLE IN THE BALLOON. THEREFORE, IT WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052135 ↗
• MalfunctionMay 24, 2016Hole In Material; Use of Device Problem; Hole In Material; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE DUODENAL PAPILLA, THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE SURGEON PLACED THE BALLOON INTO THE POSITION THROUGH THE ENDOSCOPE. THEN INJECT [FLUID WAS INJECTED] AND FOUND THAT THE BALLOON WAS LEAKING. THE PHYSICIAN WITHDREW THE DEVICE AND REPLACED WITH A NEW ONE INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5676456 ↗