Quantum TTC G22656Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002226562), received between Apr 12, 2016 and Sep 19, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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-0462-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019Material Puncture/Hole; Material Puncture/Hole

  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 THE BALLOON IS BROKEN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON (B)(6) 2019, IT WAS REPORTED THAT THE BALLOON WAS USED IN THE DUODENAL PAPILLA. 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 9089786 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem; Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE BALLOON COULD NOT BE INFLATED DURING THE PROCEDURE. THE USER RETRACTED THE DEVICE AND INFLATED IT OUTSIDE OF THE PATIENT [WHICH IS WHEN THEY] FOUND OUT THERE WAS A LEAKING ISSUE. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 06/10/2019: THE DEVICE WAS USED IN THE DUODENAL PAPILLA. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8749404 ↗
• MalfunctionDec 21, 2017Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN CHOSE A COOK QUANTUM TTC BILIARY BALLOON DILATOR (QBD-8X3). [THE DEVICE WAS] ADVANCED ALONG THE WIRE GUIDE TO THE DUODENAL PAPILLA. A COOK QUANTUM BILIARY INFLATION DEVICE (QBID-1) WAS USED TO INFLATE THE BALLOON WITH WATER. THE BALLOON COULD NOT BE INFLATED DUE TO LEAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7140367 ↗
• MalfunctionJun 2, 2017Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE ADDITIONAL INFORMATION SECTION FOR THIS JUSTIFICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6608986 ↗
• MalfunctionMay 15, 2017Burst Container or Vessel; Off-Label Use; Burst Container or Vessel; Off-Label Use

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE USER ADVANCED THE DEVICE TO DUODENAL PAPILLA POSITION AND BEGAN TO INFLATE WITH WATER BY COOK QUANTUM INFLATION DEVICE. THE DEVICE COULD NOT INFLATE ENTIRELY. THE USER WITHDREW THE DEVICE AND TESTED IT OUTSIDE ENDOSCOPE. THE DEVICE WAS FOUND TO BE LEAKING. THEY CUT THE DUODENAL PAPILLA WITH AN ELECTROTOME INSTEAD. THE FOLLOWING WAS RECEIVED 05/04/2017: IT WAS CONFIRMED THAT THE USER WAS ATTEMPTING TO DILATE THE PAPILLA [AGAINST INTENDED USE].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6566708 ↗
• MalfunctionNov 21, 2016Hole In Material; Improper or Incorrect Procedure or Method; Hole In Material; Improper or Incorrect Procedure or Method

  DURING A DUODENAL PAPILLA SPHINCTER DILATATION PROCEDURE, THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. THE USER ADVANCED THE QUANTUM TTC BILIARY BALLOON DILATOR INTO THE ENDOSCOPE CHANNEL TO THE DUODENAL PAPILLA. PRESS [WHILE DILATING] THE BALLOON, THE DEVICE WAS FOUND TO BE LEAKING. THE FAULTY DEVICE WAS REPLACED WITH ANOTHER BRAND OF DEVICE TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6116392 ↗
• MalfunctionAug 10, 2016Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK QUANTUM TTC BILIARY BALLOON DILATOR. AS REPORTED TO CUSTOMER RELATIONS VIA ATTACHED COMPLAINT FORM, "THE DOCTOR INFORMED THAT WHEN HE TRIED TO INSUFLATE THE BALLOON IT BURST. THEN, HE OPENED A NEW BALLOON TO FINISH THE PROCEDURE." ON 07/20/2016, CLARIFICATION WAS RECEIVED THAT THE PROCEDURE WAS BEING PERFORMED IN THE PAPILLA. ON 07/28/2016, THE FOLLOWING WAS RECEIVED FROM THE DISTRIBUTOR: "THERE WAS A STENOSIS AND THEY HAD TO ACCESS WITH THE BALLOON THROUGH THE PAPILLA TO DO THE EXPANSION OF THE DUODENAL CHOLEDOCAL ANASTOMOSIS. SO, THE ACCESS WAS THROUGH THE PAPILLA, BUT THE PROBLEM WAS IN THE DUODENAL CHOLEDOCAL ANASTOMOSIS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5864470 ↗
• MalfunctionJul 22, 2016Hole 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. THE PHYSICIAN FOUND THAT THE BALLOON CANNOT BE INFLATED WITH THE COOK QUANTUM BILIARY INFLATION DEVICE AND A LEAK WAS FOUND AFTER INTRODUCING [THE BALLOON] INTO THE BILIARY TRACT [PAPILLA]. THE DEVICE WAS REMOVED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5815418 ↗
• MalfunctionApr 12, 2016Hole In Material; Use of Device Problem; Hole In Material; Use of Device Problem

  THE FOLLOWING INFORMATION WAS PROVIDED VIA THE COOK SHARED SERVICE CENTER ON (B)(6) 2016: THE PHYSICIAN USED THE COOK QUANTUM TTC BILIARY BALLOON DILATOR FOR AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) TO REMOVE A COMMON BILE DUCT STONE. FIRST, THE ENDOSCOPE WAS INSERTED NEAR THE PAPILLA AREA FOLLOWED BY WIRE GUIDED CANNULATION (OLYMPUS/VISIGLIDE 2 WIRE GUIDE) IN THE COMMON BILE DUCT. THEN, THE QUANTUM TTC BILIARY BALLOON DILATOR WAS INSERTED INTO PAPILLA OVER THE WIRE GUIDE. THE USER ATTEMPTED TO INFLATE THE BALLOON, HOWEVER THE BALLOON WOULD NOT INFLATE DUE TO A HOLE. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. ON 04/04/2016, CLARIFYING INFORMATION WAS RECEIVED CONFIRMING THAT THE COMPLAINT DEVICE WAS USED IN THE PAPILLA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5569573 ↗