Fusion Quattro G48225Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002482258), received between Apr 8, 2016 and Aug 17, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280280 ↗
• MalfunctionMar 26, 2026Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE BALLOON COULD BE HEARD AUDIBLY POPPING ON FIRST ATTEMPT TO TRAWL STONES. INITIALLY THIS WAS PUT DOWN TO A SHARP STONE BEING TRAWLED BUT ON INSPECTION IT APPEARED THERE IS NO BALLOON REMAINING ATTACHED TO THE CATHETER [SUBJECT OF REPORT]. THE DETACHED BALLOON MATERIAL REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24705840 ↗
• MalfunctionMar 5, 2026Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED THREE COOK FUSION QUATTRO EXTRACTION BALLOONS. IT WAS INITIALLY REPORTED [THAT] BALLOONS HAD [MALFUNCTIONED]. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. UPON INVESTIGATION OF RETURNED DEVICE ON 10FEB2026, IT WAS FOUND THAT DEVICE #2 AND #3 APPEARED TO HAVE PIECES MISSING [SUBJECT OF REPORT]. ALTHOUGH IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY, THE LOCATION OF THE MISSING BALLOON PIECES IS UNKNOWN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24519156 ↗
• MalfunctionDec 31, 2025Material Rupture; Material Rupture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] BALLOON HAD BURST. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. UPON INVESTIGATION OF RETURNED DEVICE ON 08DEC2025, IT WAS FOUND THAT THE BALLOON WAS MISSING PIECES [SUBJECT OF REPORT]. ALTHOUGH IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY, THE LOCATION OF THE MISSING BALLOON PIECES IS UNKNOWN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23935633 ↗
• MalfunctionDec 29, 2025Material Rupture; Material Rupture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] BALLOON HAD BURST. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. UPON INVESTIGATION OF RETURNED DEVICE ON 03DEC2025, IT WAS FOUND THAT THE BALLOON WAS MISSING PIECES [SUBJECT OF REPORT]. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23912979 ↗
• MalfunctionDec 22, 2025Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE, SO [PHYSICIAN] USED FORCE TO PULL IT OUT AND CHANGED TO COMPETITOR BRAND BALLOON TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23871946 ↗
• InjuryDec 10, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP], THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE BALLOON BURST WHILE IN USE. CUSTOMER WAS ADVISED THAT THE CASE RESULTED IN PANCREATITIS [SUBJECT OF REPORT] AND PATIENT DIED FOLLOWING THE PROCEDURE. AFTER MEETING WITH PHYSICIAN AND INVESTIGATION COMPLETED BY CORONER, THE FINDINGS WERE THAT THE EXTRACTION BALLOONS DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH THE DEATH AND WAS CONCLUDED DUE TO BE ATTRIBUTED TO OTHER FACTORS OUTSIDE OF THE PROCEDURE. IT WAS REPORTED THAT NO BALLOON FRAGMENTS WERE RETAINED IN THE PATIENT, AND THE PANCREATIC DUCT WAS NOT CANNULATED. THE MOST PLAUSIBLE ETIOLOGY FOR THE PANCREATITIS REMAINS THAT THE PATIENT EXPERIENCED STANDARD POST-ERCP PANCREATITIS, A KNOWN COMPLICATION OF THE ERCP PROCEDURE. THEREFORE, THE LIKELIHOOD THAT THE BALLOON MALFUNCTION CAUSED OR CONTRIBUTED TO THE PANCREATITIS IS CONSIDERED LOW. THIS MDR IS BEING SENT TO CAPTURE THE CLINICAL SITUATION OF PANCREATITIS.

  Patient problems: Pancreatitis

  MAUDE report 23770874 ↗
• MalfunctionSep 15, 2025Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE. AS SUCH, WHEN DEFLATING THE BALLOON, THE STOP COCK WAS TURNED, THE SYRINGE WAS NOT REMOVED AND THE BALLOON WAS STILL PARTIALLY INFLATED. SINCE NO STONES WERE SEEN ON CONTRAST IMAGING, THE TEAM DECIDED TO STOP THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23057497 ↗
• MalfunctionApr 25, 2025Material Rupture; Material Rupture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) , THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. IT WAS REPORTED [THAT] THE BALLOON POPPED ON THE SECOND OR THIRD SWEEP IN THE COMMON BILE DUCT [NO REPORTABLE INFORMATION AT THIS TIME]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE DEVICE WAS RECEIVED FOR EVALUATION ON 01APR2025. IT WAS DETERMINED THAT THE BALLOONS APPEARS TO BE MISSING A SECTION [SUBJECT OF REPORT]. THE DETACHED BALLOON SECTION LOCATION IS UNKNOWN; IT MAY HAVE REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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: Foreign Body In Patient

  MAUDE report 21913330 ↗
• MalfunctionSep 5, 2019Material Fragmentation; Material Fragmentation

  DURING A STONE REMOVAL PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. PER THE USER, THE BALLOON DID NOT LAST THE ENTIRE CASE, IT ONLY WORKED FOR "A COUPLE INFLATIONS." IT IS UNKNOWN IF CUSTOMER NEEDED ANOTHER BALLOON TO COMPLETE THE PROCEDURE. PER THE COOK SALES REPRESENTATIVE, THE BALLOON WAS TESTED PRIOR TO USE AND WAS HOLDING PRESSURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 14-AUG-2019 AND THE EVALUATION DETERMINED THAT A PIECE OF THE BALLOON WAS MISSING. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER, THE LOCATION OF THE MISSING PORTION IS UNKNOWN. 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 8967524 ↗
• MalfunctionMar 4, 2019Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. UPON EXTRACTING STONES FROM THE BILE DUCT, THE BALLOON SNAPPED (RUPTURED). THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 02/11/2019. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT THERE ARE PIECES OF THE BALLOON MATERIAL MISSING AND WERE NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING PIECES IS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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 8388132 ↗
• MalfunctionMar 4, 2019Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. UPON EXTRACTING STONES FROM THE BILE DUCT, THE BALLOON SNAPPED (RUPTURED). THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2019. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT THERE WERE PIECES OF THE BALLOON MATERIAL MISSING AND WERE NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING PIECES WAS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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 8388130 ↗
• MalfunctionDec 15, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IN PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND PRIOR TO BEING PLACED DOWN THE ENDOSCOPE, IT WAS NOTED THAT THE FUSION QUATTRO EXTRACTION BALLOON DID NOT HAVE A WIRE PORT CUT INTO THE CATHETER. THEY COULD SEE WHERE [THE WIRE PORT] WAS SUPPOSED TO BE BUT IT WAS NOT THERE. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS EVALUATED ON 11/21/17. THE IDE [INTRADUCTAL EXCHANGE] PORT WAS FOUND TO BE DAMAGED AND PROTRUDING.

  Patient problems: No Patient Involvement

  MAUDE report 7122914 ↗
• MalfunctionDec 15, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN CHOSE A FUSION QUATTRO EXTRACTION BALLOON. THE BALLOON HAD A SLOW LEAK. THE DEVICE WAS RECEIVED FOR EVALUATION ON 11/30/17 AND WAS FOUND TO HAVE DAMAGE TO THE INTRADUCTAL EXCHANGE (IDE) PORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7122667 ↗
• InjuryOct 19, 2017Detachment Of Device Component; Off-Label Use; Improper or Incorrect Procedure or Method; Detachment Of Device Component; Off-Label Use; Improper or Incorrect Procedure or Method

  DURING BALLOON TAMPONADE OF FISTULA TRACT, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. PER MEDWATCH FORM ((B)(4)): "WHEN ATTEMPTING TO REMOVE THE BALLOON BY [GASTROINTESTINAL] GI, IT WAS NOTICED THAT THE BALLOON HAD BROKEN OFF AND COULD NOT BE REMOVED BY HEMOSTAT. SINCE THE BALLOON BROKE FREE FROM THE APPARATUS WHICH WAS MAINTAINING INFLATION, IT SHOULD NO LONGER BE INFLATED. SMALL, FLEXIBLE CATHETER MAY WELL PASS SPONTANEOUSLY PER RECTUM. DOCTOR TO FOLLOW PATIENT WITH SERIAL KUBS-KIDNEYS, URETERS, AND BLADDER. WHAT WAS THE ORIGINALLY INTENDED PROCEDURE? BALLOON TAMPONADE OF FISTULA TRACT TO STOP BLEEDING OF ENTEROCUTANEOUS FISTULA. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THIS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULD NOT GET IT TO WORK OR STOPPED WORKING)."

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 6962018 ↗
• MalfunctionJun 8, 2017Deflation Problem; Deflation Problem

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED TWO (2) COOK FUSION QUATTRO EXTRACTION BALLOONS, THEY WERE PREPPING THE DEVICES AND HAVING ISSUES WITH THE INFLATION SYRINGE STICKING. THIS CAUSED THE BALLOONS NOT TO DEFLATE. THIS OCCURRED WITH TWO DEVICES OF SAME LOT IN ONE CASE. THE DEVICES DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6625033 ↗
• MalfunctionMay 25, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THE FOLLOWING WAS REPORTED ON (B)(6) 2017: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. THE BALLOON LOSES AIR SLOWLY IN THE DUCT BUT NOT IN THE DUODENUM. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. ON 05/01/2017, THE DEVICE WAS RETURNED FOR EVALUATION. THE INTRADUCTAL EXCHANGE (IDE) PORT WAS FOUND TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591680 ↗
• MalfunctionMar 31, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE WIRE OUT OF THE SIDE PORT. THEY WERE ABLE TO USE THE WIRE GUIDE, BUT A LONG-WIRE EXCHANGE WAS PERFORMED INSTEAD OF A SHORT-WIRE EXCHANGE. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 03/06/2017. THE INTRADUCTAL EXCHANGE PORT WAS FOUND TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449441 ↗
• MalfunctionFeb 10, 2017Material Separation; Material Separation

  THE FOLLOWING WAS RECEIVED ON (B)(6) 2016: DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. THE BALLOON BURST DURING THE PROCEDURE. THE COMPLAINT DID NOT INCLUDE REPORTABLE INFORMATION AT THAT TIME. ON 01/16/2017, THE DEVICE WAS RECEIVED FOR EVALUATION, AND THERE WAS A MISSING PORTION OF THE BALLOON.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6321988 ↗
• MalfunctionNov 29, 2016Material Protrusion/Extrusion; Material Protrusion/Extrusion

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. WHEN THE FUSION QUATTRO EXTRACTION BALLOON WAS TAKEN OUT OF THE PACKAGE, IT WORKED FINE. THEY WERE INSIDE THE DUCT DOING A BALLOON SWEEP WHEN DIFFICULTY WAS EXPERIENCED IN REMOVING THE BALLOON. THE COOK FUSION PRELOADED WITH ACROBAT WIRE GUIDE WANTED TO COME OUT WITH IT (SEE RELATED MDR REPORT NUMBER 1037905-2016-00441). WHEN THE COOK FUSION QUATTRO EXTRACTION BALLOON WAS RECEIVED FOR EVALUATION ON 11/04/2016, THE INTRADUCTAL EXCHANGE (IDE) PORT WAS NOTED TO BE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6131571 ↗
• MalfunctionSep 9, 2016Deflation Problem; Deflation Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. AS REPORTED TO CUSTOMER RELATIONS: "THEY HAD A DIFFICULT TIME DEFLATING THE BALLOON. THE PHYSICIAN DID A SWEEP AND DID NOT NEED ANOTHER BALLOON."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5938980 ↗
• MalfunctionApr 8, 2016Burst Container or Vessel; Shelf Life Exceeded; Burst Container or Vessel; Shelf Life Exceeded

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION QUATTRO EXTRACTION BALLOON. THE ERCP TEAM OBSERVED THAT THE NUMBER OF EXTRACTION BALLOONS PUNCTURED DURING THE PROCEDURE HAVE INCREASED IN THE LASTS TWO MONTHS. THEY CONTACTED THE COOK REPRESENTATIVE WHEN THEY NEED TO USE 4 DEVICES IN ONLY ONE PROCEDURE. THEY EXPLAINED THAT WHEN DO THE FIRST PASS INSIDE THE BILE DUCT, THE BALLOONS START TO BUBBLE UP [INFLATE] AND THEN THE BALLOON WAS BROKEN [RUPTURES]. AFTER THAT, THE PHYSICIAN NEEDS TO OPEN ANOTHER BALLOON IN ORDER TO FINISH THE PROCEDURE. THE PRODUCT WAS USED WITH A DUODENOSCOPE OLYMPUS 145. THE DEVICE WAS RECEIVED FOR EVALUATION ON 03/15/2016, DURING THIS EVALUATION IT WAS NOTED THAT BALLOON MATERIAL WAS MISSING.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 5562896 ↗