Fusion G34693Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10827002346939), received between Apr 26, 2016 and Mar 7, 2022 — classified as 1 injury, 69 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2022Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS REPORTED THAT THE HYDROPHILIC COATING STRIPPED ON THE GUIDE WIRE AND AS THE PHYSICIAN WAS PULLING THE WIRE OUT, A PIECE OF THE HYDROPHILIC COATING GOT CAUGHT AND BROKE OFF IN THE PATIENT. THE PLASTIC STENT WAS PLACED AND THEN THE PHYSICIAN USED A COOK SNARE DEVICE TO RETRIEVE THE PIECE OF HYDROPHILIC COATING FROM THE PATIENT. THE DETACHED PIECE OF HYDROPHILIC COATING WAS RETRIEVED WITH A COOK SNARE. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, AND ACCORDING TO THE INITIAL REPORTER THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685103 ↗
• MalfunctionOct 11, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS INITIALLY REPORTED THAT THE PHYSICIAN CANNULATED INITIALLY AND PERFORMED A SPHINCTEROTOMY. THEN, THE SPHINCTEROTOME WAS REMOVED. THEY HAD DIFFICULTY WITHDRAWING IT FROM THE WIRE LOCK. THEY WERE ABLE TO GET IT OUT. AT THAT POINT, THEY PASSED AN EXTRACTION BALLOON THOUGH THE SCOPE AND PERFORMED BALLOON SWEEPS. AFTER THAT POINT, THE PHYSICIAN THEN PASSED THE SPHINCTEROTOME THROUGH THE SCOPE AND HAD TROUBLE AGAIN PASSING IT THROUGH THE WIRE LOCK. ONCE THE TOME WAS PASSED THROUGH AND VISIBLE IN THE DUODENUM, THE CUTTING WIRE WAS BROKEN. THEY REMOVED IT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT THE CUTTING WIRE SECURING COMPONENT (ANCHOR) HAS SEPARATED FROM THE CATHETER (W/ DETACHMENT) RESULTING IN TIP WILL NOT BOW. [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 INITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12608218 ↗
• MalfunctionOct 11, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS INITIALLY REPORTED THAT THE SPHINCTEROTOME WAS USED TO CANNULATE AND WAS WITHDRAWN FROM THE SCOPE. THE PHYSICIAN DECIDED TO GO BACK-DOWN WITH THE SPHINCTEROTOME AND THE CUTTING WIRE WAS BROKEN. AT THIS TIME, THE PHYSICIAN ELECTED TO PLACE A PLASTIC STENT TO COMPLETE THE INTENDED PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT THE CUTTING WIRE SECURING COMPONENTS (ANCHORS) HAS SEPARATED FROM THE CATHETER (W/ DETACHMENT) RESULTING IN TIP WILL NOT BOW. [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 12606944 ↗
• MalfunctionOct 6, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. IT WAS REPORTED THAT THE PHYSICIAN HAD A WIRE GUIDE IN PLACED, PUT A BALLOON OVER IT AND SAW ON X-RAY THAT THE COATING AROUND THE WIRE GUIDE WAS COMING OFF. IT LOOKED TO THE PHYSICIAN LIKE IT WAS AROUND THE 25CM MARK WHERE IT STARTED TEARING OFF. THE PHYSICIAN CHANGED OUT THE WIRE GUIDE FOR A SINGLE WIRE GUIDE (NOT A PRE-LOADED) OR POSSIBLY ANOTHER WIRE GUIDE OF THE SAME KIND OF DEVICE. 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 12586982 ↗
• MalfunctionJul 13, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE PHYSICIAN WAS HAVING DIFFICULTY ADVANCING THE BALLOON INSIDE THE BILE DUCT OVER THE WIRE GUIDE BUT WAS EVENTUALLY ABLE TO ADVANCE THE BALLOON PAST THE CYSTIC DUCT. WHEN PULLING THE BALLOON BACK TO SWEEP THE DUCT, THE BLACK COATING OF THE PRELOADED ACROBAT WIRE HAD PEELED AND WAS CRINKLED UP AT THE IDE PORT OF QUATTRO BALLOON. THE PHYSICIAN DECIDED TO PULL THE WIRE OUT OF ENDOSCOPE AND FINISH THE BALLOON SWEEPS WITHOUT A WIRE GUIDE IN PLACE AND WAS ABLE TO COMPLETE 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 12159205 ↗
• MalfunctionFeb 3, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME FOR A PANCREATIC CANCER METAL STENT CASE. THE WIRE THAT WAS PRELOADED IN THE SPHINCTEROTOME STRIPPED WHEN A BALLOON WAS USED DURING FIRST EXCHANGE. THE WIRE STRIPPED SO BADLY IT GRABBED ONTO THE BALLOON CATHETER AND LOST WIRE GUIDE CANNULATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 11274131 ↗
• MalfunctionDec 22, 2020Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE PLASTIC JACKET [HYDROPHILIC COATING] AROUND THE CORE OF THE WIRE STRIPPED, EXPOSING THE METAL CORE [COATING DAMAGE]. THE BALLOON [BEING USED WITH THE WIRE GUIDE] WAS REMOVED AND REPLACED THE WIRE GUIDE WITH A NEW WIRE GUIDE [LOST WIRE GUIDE ACCESS]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE NEW WIRE GUIDE. THE DOCTOR CAREFULLY INSPECTED THE DAMAGED WIRE GUIDE AND DETERMINED THAT NOTHING WAS LEFT IN THE PATIENT. 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 11057766 ↗
• InjuryNov 18, 2020Fracture; Material Separation; Fracture; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE CUTTING WIRE OF THE SPHINCTEROTOME BROKE. THEY HAD TO SEARCH FOR THE BROKEN CUTTING WIRE THAT WAS IN THE PATIENT'S DUODENUM. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: WHEN CUTTING THE PAPILLA, THE CUTTING WIRE BROKE COMPLETELY AND WAS PARTIALLY IN THE WORKING CHANNEL OF THE ENDOSCOPE. THE DOCTOR TOOK A SWAB (BRUSH FOR CLEANING ENDOSCOPES) AND PUSHED THE CUTTING WIRE IN THE DUODENUM. RAPIDLY, HE TOOK A BIOPSY FORCEPS TO CATCH THE WIRE GUIDE [CUTTING WIRE]. ONCE CAUGHT, THEY REMOVED THE ENDOSCOPE TOTALLY OUT WITH THE BIOPSY INTO THE WORKING CHANNEL IN ORDER NOT TO LOOSE THE CUTTING WIRE. NO DAMAGES WAS OBSERVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED THE CUTTING WIRE TO BE REMOVED FROM THE PATIENT 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 10860487 ↗
• MalfunctionSep 21, 2020Fracture; Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDES. THE CUTTING WIRE BROKE DURING THE PROCEDURE. THIS EVENT WAS NOT REPORTABLE. ON 27-AUG-2020 THE DEVICES WERE RETURNED WITH A PROCEDURAL PHOTO. THE PHOTO SHOWS ONE (1) OF THE DEVICES WHERE THE CUTTING WIRE PENETRATED THE MUCOSA IN AN INTENDED AREA [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 Consequences Or Impact To Patient

  MAUDE report 10559348 ↗
• MalfunctionApr 9, 2020Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED AN FS-OMNI FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. AFTER THE SPHINCTEROTOMY, THE DOCTOR USED A FUSION QUATTRO EXTRACTION BALLOON. THE BALLOON WAS STUCK ON THE WIRE GUIDE AND IT WAS IMPOSSIBLE TO MOVE THE BALLOON. THE WIRE GUIDE LOOPED IN THE DUODENUM BECAUSE OF THE 9 CM SHORT WIRE GUIDE OUTLET ON THE CATHETER. THE DOCTOR REMOVED THE WIRE GUIDE AND BALLOON AND TO START OVER THE PROCEDURE WITH SPHINCTEROTOME AND WIREGUIDE AND THEN BALLOON INSTEAD OF FS-OMNI FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THIS EXTENDED THE PROCEDURE TIME. 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 9946238 ↗
• MalfunctionApr 9, 2020Malposition of Device; Malposition of Device

  DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE SPHINCTEROTOME WAS COMPLETELY TWISTED AND IT WAS IMPOSSIBLE TO DO THE SPHINCTEROTOMY BECAUSE THE CUTTING WIRE WAS NOT IN THE AXIS [INCORRECT ORIENTATION]. THE [PHYSICIAN] DECIDED TO USE A NEW ONE [A SECOND DEVICE 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 Consequences Or Impact To Patient

  MAUDE report 9944243 ↗
• MalfunctionFeb 7, 2020Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE CATHETER WAS FLUSHED WITH SALINE AT THE WIRE-PORT. THE GUIDEWIRE ADVANCED WITHOUT DIFFICULTY, THEN LOCKED ON A COOK FUSION WIRE LOCK. DURING THE REMOVAL OF THE CATHETER, IT WAS NOTICED (ENDOSCOPICALLY) A BLACK STRIPPING OF THE GUIDEWIRE [COATING DAMAGE]. AFTER REMOVAL OF THE SPHINCTEROTOME, A COOK QUATTRO EXTRACTION BALLOON WAS ADVANCED DOWN OVER THE GUIDEWIRE. IT MET RESISTANCE AT THE PEELED WIRE PORTION OF THE GUIDEWIRE. AT THIS POINT, THE PHYSICIAN REMOVED THE GUIDEWIRE AND BALLOON AND PERFORMED A PROCEDURE WITH ANOTHER COOK FUSION OMNI-TOME LOADED WITH A MET WIRE WITHOUT DIFFICULTY [LOST WIRE GUIDE ACCESS]. 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 9680793 ↗
• MalfunctionFeb 3, 2020Malposition of Device; Malposition of Device

  DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE ORIENTATION WAS INCORRECT WHEN THE DEVICE EXITED THE ENDOSCOPE (APPROXIMATELY 3-4 CM) AND WAS POINTING SOUTH/DOWN INSTEAD OF UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 9662197 ↗
• MalfunctionJan 27, 2020Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE. THE PHYSICIAN WAS UNABLE TO REMOVE THE SPHINCTEROTOME [OMNI-TOME] OUT OF THE SCOPE OVER THE WIRE. AFTER TROUBLESHOOTING, THE OMNI-TOME COULD NOT BE REMOVED WHILE LEAVING THE WIRE IN PLACE, SO BOTH THE ACROBAT WIRE AND OMNI-TOME HAD TO BE REMOVED. A NEW OMNI-TOME WITH WIRE WAS OPENED AND THE PHYSICIAN HAD TO RECANNULATE TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS OBSERVED ON THE COMPLAINT DEVICE THAT THE ACROBAT WIRE COATING WAS BUNCHED UP WHERE IT WAS EXITING THE OMNI-TOME (THE OMNI-TOME HAD BEEN PREVIOUSLY STRIPPED), AND THE WIRE WAS EXITING THE BREAK THROUGH CHANNEL RIGHT NEAR THE METAL BAND. THE COATING WAS BUNCHED UP PREVENTING THE OMNI-TOME FROM BEING PULLED UP AND OUT OVER THE WIRE. 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 9635069 ↗
• MalfunctionOct 21, 2019Peeled/Delaminated; Positioning Problem; Peeled/Delaminated; Positioning Problem

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. PATIENT WAS IN FOR AN ERCP WITH PLASTIC STENT REMOVAL. IT WAS CHOSEN TO CANNULATE WITH A WIRE THROUGH THE PLASTIC STENT AND REMOVE THE STENT OVER THE PREPOSITIONED WIRE GUIDE. THE FUSION SPHINCTEROTOME WITH ACROBAT WIRE GUIDE WAS ENGAGED WITH THE PLASTIC STENT, AND THE ACROBAT WIRE WAS FED UP THE STENT AND CONFIRMED PLACEMENT WITH FLUOROSCOPY. THE PRELOADED WIRE GUIDE WAS OPENED AND CLOSED AROUND THE PLASTIC STENT [SIC], WHILE GRASPING THE STENT WITH THE SNARE, THE PLASTIC STENT WAS PULLED OUT OF THE PATIENT LEAVING THE WIRE GUIDE IN THE COMMON BILE DUCT (CBD). A COOK FUSION QUATTRO EXTRACTION BALLOON WAS ADVANCED OVER THE PREPOSITIONED WIRE GUIDE. DIFFICULTY WAS ENCOUNTERED WHEN THE BALLOON REACHED THE DISTAL TIP OF THE ENDOSCOPE AND COULD NOT BE ADVANCED OUT OF THE ENDOSCOPE. THE BALLOON WAS REMOVED AND THE ENDOSCOPE CHANNEL WAS FLUSHED. A SECOND ATTEMPT TO PASS THE BALLOON OVER THE PREPOSITIONED WIRE GUIDE WAS MADE. THE BALLOON STILL COULD NOT BE ADVANCED OVER THE PREPOSITION WIRE GUIDE INTO THE BILE DUCT. A BLACK PIECE OF MATERIAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216270 ↗
• MalfunctionOct 8, 2019Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE CUTTING WIRE DETACHED FROM SPHINCTEROTOME DURING OPERATION. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED A PART OF THE DEVICE IS MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9167599 ↗
• MalfunctionJul 11, 2019Material Separation; Material Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO THE FDA ON (B)(6) 2019. "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH WIRE GUIDE SPHINCTEROTOME. THE COATING STRIPPED FROM THE [PRE-LOADED] WIRE GUIDE (SEE MEDWATCH REPORT 1037905-2019-00286)." ON (B)(6) 2019, THE DEVICE WAS RETURNED WITH THE CUTTING WIRE SECURING COMPONENT SEPARATED (SUBJECT OF THIS REPORT). 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. THE ADDITIONAL QUESTIONS STATE THAT NO PORTION OF THE DEVICE DETACHED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8781139 ↗
• MalfunctionJun 28, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE WIRE GUIDE STRIPPED DURING THE BALLOON SWEEP. NOTHING DETACHED INSIDE OF THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE PHYSICIAN USED A COMPETITORS WIRE GUIDE AND 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 Consequences Or Impact To Patient

  MAUDE report 8744638 ↗
• MalfunctionJun 24, 2019Material Frayed; Peeled/Delaminated; Material Frayed; Peeled/Delaminated

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ON (B)(6) 2019: "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE WIRE STRIPPED ITS COATING. THE PROCEDURE WAS PROCEEDING SMOOTHLY UNTIL A PIGTAIL STENT WAS DEPLOYED. THIS PROVED TO BE MUCH HARDER THAN ANTICIPATED, ALTHOUGH IT WAS EVENTUALLY DEPLOYED. UPON INSPECTION OF THE WIRE GUIDE AT THE END OF THE CASE, IT WAS OBSERVED THAT THE DISTAL COATING OF APPROXIMATELY 10 CM HAD SHEARED OFF THE BASE WIRE. THE DEVICE WAS EVALUATED ON (B)(6) 2019 AND A PORTION OF THE WIRE GUIDE COATING MEASURING APPROXIMATELY 10.6 CM APPEARS TO BE MISSING. THE INITIAL REPORT STATED 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8726942 ↗
• MalfunctionMay 28, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE COATING STRIPPED FROM THE [PRE-LOADED] WIRE GUIDE. THE INFORMATION RECEIVED STATES THAT NO PORTION OF THE DEVICE DETACHED IN THE PATIENT. 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 8647682 ↗
• MalfunctionMay 28, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE COATING STRIPPED FROM THE [PRE-LOADED] WIRE GUIDE. THE INFORMATION PROVIDED STATES THAT NO PORTION OF THE DEVICE DETACHED IN THE PATIENT. 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 8647679 ↗
• MalfunctionApr 18, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH WIRE GUIDE SPHINCTEROTOME. THE PRE-LOADED WIRE GUIDE STRIPPED WHEN DOING A BALLOON SWEEP. THE WIRE APPEARED STRIPPED AT APPROXIMATELY THE 18 CM TO THE 22 CM MARK. 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 8527856 ↗
• MalfunctionMar 4, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH WIRE GUIDE SPHINCTEROTOME. THE PRE-LOADED WIRE GUIDE STRIPPED ITS COATING DURING 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 Consequences Or Impact To Patient

  MAUDE report 8387260 ↗
• MalfunctionDec 17, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE SPHINCTEROTOME. THE WIRE COATING STRIPPED OFF FROM THE CORE. THE GUIDE WIRE COATING DELAMINATED [PEELED] DURING THE PROCEDURE AND NEEDED REPLACING. 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 8170554 ↗
• MalfunctionDec 14, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE. AN ACROBAT WIRE ISSUE [OCCURRED]. BETWEEN 16 AND 18 CM FROM THE DISTAL (FLOPPY) END, DURING AN EXCHANGE (IMMEDIATELY PRECEDING BALLOON SWEEP), THE CUSTOMER NOTICED BUNCHING UP OF THE MATERIAL [COATING]. THE PHYSICIAN REMOVED THE BALLOON AND WIRE GUIDE FROM THE PATIENT [LOST WIRE GUIDE ACCESS], TO EXAMINE THEM, AT WHICH POINT THEY NOTICED THE OUTER COATING HAD BEEN STRIPPED AWAY. THE CUSTOMER WITHDREW IT AND USED AN ALTERNATE PRODUCT TO COMPLETE THE CASE. 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 8163933 ↗