MAUDE Adverse Event Report: FUJIFILM TECHNO PRODUCTS CO., LTD. FUJIFILM; CO2 REGULATOR

Model Number GW-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Death (1802)

Event Type  Death  

Manufacturer Narrative

The case report describes the death of a patient undergoing a complex, interventional biliary procedure that used various fujifilm products, including the (b)(4).The gw-1 is a co2 regulator that appears to have been responsible for the introduction and maintenance of co2 gas levels during the procedure.The gw-1 co2 regulator is not marketed or sold in the u.S.However, a similar product, the gw-100 (k133976) is marketed and sold in the u.S.The death of the patient involved multiple and clearly mass intravascular gas emboli, apparently introduced to the patient's circulatory system via the biliary tree.The authors speculate that the patient had a pre-existing biliovenous shunt (a rare communication between the biliary tree and the adjacent veins), a condition that can occur with long-standing infection in the biliary tree as was the case with this patient.Simply put, the infection destroys the tissue of the biliary tree and erodes into the adjacent veins.It appears that the co2 introduced via the fujifilm device entered the patient's circulation and ultimately resulted in the patient death.Given the patient death and that the gw-1 may have contributed to the gas that resulted in that death, this report is being made in an abundance of caution.In conclusion, it appears that the device performed as intended; and the presumed cause of death was a clinically unrecognized communication between the biliary tree and the patient's systemic circulation that allowed the gas emboli to occur, not the fujifilm device.A total of three mdr's will be submitted (numbered 2431293-2016-00028 through ) to include the listed concomitant devices.Customer unknown based on article.

Event Description

As written in a medical journal article: a (b)(6)-year-old woman was admitted to our hospital with a complaint of hepatolithiasis.She had undergone roux-en-y hepaticojejunostomy for choledochal cysts 34 years previously.We performed dpocs (direct peroral cholangioscopy) using a short-type double-balloon enteroscope (dbe), an ultraslim endoscope, and an endoscopic co2 regulator ((b)(4), respectively; fujifilm corp., (b)(6)) while the patient was kept adequately sedated with midazolam.We planned to perform lithotripsy of the hepatolith using a holmium:yag laser.After we had reached the anastomosis using the dbe, attempts to extract the stones through the dbe using balloon or basket catheters failed.We therefore decided to perform dpocs (direct peroral cholangioscopy) with an ultraslim endoscope passed through an overtube using a previously described method.The balloon attached to the overtube remained inflated from the time that we reached the anastomosis until the end of the procedure.We first confirmed the hepatolith was present.We then prepared the holmium:yag laser for lithotripsy for 5 minutes, while we aspirated pus and mucus discharged from the peripheral bile duct near the hepatolith.As we fractured the hepatolith with the holmium:yag laser, the patient suddenly went into shock and had a cardiac arrest.Despite immediate cardiomegaly resuscitation and injection of flumazenil, she died.A computed tomography (ct) scan performed during resuscitation revealed multiple gas emboli in the systemic arteries and veins.Pathological examination later revealed hepatic abscesses, inflammation surrounding the hepatolith, intravascular gas, and systemic gas emboli.There was no evidence of a patent foramen ovale.The cause of death was systemic gas embolism.We believe aspiration of pus and mucus prior to lithotripsy may have opened a pre-existing biliovenous shunt.Source: title: development of fatal systemic gas embolism during direct peroral cholangioscopy under carbon dioxide insufflation.Author: hiromu kondo, itaru naitoh, takahiro nakazawa, kazuki hayashi, yuji nishi, shuichiro umemura, takashi joh.Publication: endoscopy.Publisher: thieme.Date: jan 1, 2016.Copyright 2016, rights managed by georg thieme verlag kg stuttgart new york.

• Brand Name: FUJIFILM
• Type of Device: CO2 REGULATOR
• Manufacturer (Section D): FUJIFILM TECHNO PRODUCTS CO., LTD.; 2-1-3 kitayuguchi; hanamaki city, iware, 025-0 301; JA 025-0301
• Manufacturer (Section G): FUJIFILM TECHNO PRODUCTS CO., LTD.; 2-1-3 kitayuguchi; hanamaki city, iware, 025-0 301; JA 025-0301
• Manufacturer Contact: john brzezinski ; 10 high point drive; wayne, NJ 07470 ; 9736862430
• MDR Report Key: 5816393
• MDR Text Key: 50289191
• Report Number: 2431293-2016-00028
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: GW-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR