MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. FIELDER 18; ENDOSCOPIC GUIDE WIRE

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: manufacturing site could not be identified because the product lot number information was not available.Device evaluation could not be performed because the affected device was not returned.Lot history records review could not be conducted because lot information was unavailable.All the shipped products were inspected in the production process and satisfied the product specifications and release criteria; therefore, it was concluded that there was no anomaly in product quality.Although no information mentioned that the fielder 18 was involved in the adverse event in the literature, it was unable to completely rule out a possibility that fielder 18 might have caused or contributed to the adverse event.Referring to known similar events, it was concluded this event was associated with digestive organ condition with altered anatomical structure and/or the operator's technique.No capa will be taken.Instructions for use (ifu) states: [precautions] ~ operate this guide wire or the interventional device slowly and carefully while monitoring the movement and position of this guide wire within the endoscope's field of view or under fluoroscopy.~ do not use this guide wire with metal tipped catheters other than asahi intecc's endoscope dilators.[malfunction and adverse effects] ~ peritonitis.

Event Description

It was reported through a literature that an asahi fielder 18 guide wire might have contributed to bile peritonitis.Publication: journal of hepato-biliary-pancreatic sciences 2023;30:1078-1087.Title: comparing endoscopic ultrasound-guided antegrade treatment and balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography in the management of bile duct stones in patients with surgically altered anatomy: a retrospective cohort study.Excerpt: [introduction] we conducted this study to compare eus-ag with be-ercp in the management of bds in patients with surgically altered anatomy, to evaluate the merits and demerits of each procedure, and to provide suggestions for future treatment algorithms.[methods]: this retrospective study was conducted at two tertiary care centers, gifu university hospital and gifu municipal hospital.A database analysis was performed that included all ercp and eus procedures between january 2012 and march 2021 to identify patients who met the following inclusion criteria: patients (1) who underwent eus-ag or be-ercp for bds and (2) who had a history of upper gastrointestinal surgery with roux-en-y reconstruction or billroth ii reconstruction.Patients who underwent billroth i reconstruction, child reconstruction, including the modified method, or biliary reconstruction were excluded from the study.Eus-ag: step 1: endoscopic approach using a convex-type eus scope (gf-uct260; olympus) in b-and doppler modes from the stomach or jejunal limb, the intrahepatic bile duct (ihbd) of the left lobe of the liver was assessed.Step 2: biliary access after confirmation of the absence of interposing vessels, the dilated ihbd was punctured using a 19-or 22-gauge fine-needle aspiration (fna) needle (ez shot 3 plus, olympus; sonotip pro control, medi-globe), which was primed with a contrast agent after removal of the stylet.The proper puncture was confirmed using contrast injection.A guidewire was inserted into the biliary system using an fna needle.A 0.025-inch guidewire (visiglide2, olympus; m-through, asahi intecc) was used for 19-gauge fna needles, whereas a 0.018-inch guidewire (novagold, boston scientific; fielder 18, asahi intecc) was inserted for 22-gauge needles.After guidewire insertion, the needle tract was dilated using a 7-fr bougie dilator (es dilator, zeon medical).The dilator was exchanged with an ercp catheter for an additional cholangiogram and guidewire manipulation of the duodenum through the ampulla.Be-ercp: step 1: endoscopic approach the double-balloon endoscopy system (ei-580 bt or en-450, fujifilm) was used for all procedures and was inserted into the blind end of the duodenum through the afferent limb using balloons attached to the tip of the endoscope and an overtube to shorten the intestinal tract, as previously described.Step 2: biliary access biliary duct cannulation was attempted using an ercp catheter loaded with a 0.025-inch guidewire (visiglide 2, olympus; m-through, asahi intecc) while the balloon of the overtube was inflated to hold the scope position, although the balloon attached to the scope was deflated for more flexible scope movement.After deep biliary cannulation, a cholangiogram was obtained to evaluate the size and number of bds.[results]: a total of 119 patients were identified using the database analysis.Twenty-three patients were managed with eus-ag and 96 with be-ercp.Their basic characteristics are listed in table 1.No significant differences were observed in age, sex, surgical reconstruction, size of the common bile duct and the largest bds, or the number of bds.The technical failure was salvaged percutaneous procedures in 20 patients, surgical procedures in six patients, eus-ag in two patients and conservative treatment in one patient after be-ercp.Failed eus-ag was salvaged by percutaneous procedure in five patients, be-ercp in two patients and surgical procedure in one patient.In step 2, the biliary access, the success rate of cannula insertion into the biliary system was 73.9% (95% ci: 53.2-87.7; 17/23) in eus-ag and 80.0% (95% ci: 70.1-87.2; 68/85) in be-ercp (p =.57).A biliary puncture was performed using a 19-gauge fna needle in 12 patients and a 22-gauge needle in five patients, with the accessed duct of b2 in eight patients and b3 in seven patients.The median diameter of the punctured bile duct was 4 mm (iqr, 3-5).The reasons for failed biliary access were insufficient dilation of the ihbd for a puncture in six patients during eus-ag and technical difficulty in obtaining biliary deep cannulation in 17 patients during be-ercp.[adverse events related to the procedures]: the overall adverse event rates of eus-ag and be-ercp were 17.4% (95% ci: 6.4-37.7; 4/23: bile peritonitis in three and elevation of c-reactive protein as others in one) and 7.3% (95% ci, 3.3-14.5; 7/96: pancreatitis in three and perforation in four), respectively (p =.22).Three patients with perforation after be-ercp experienced severe adverse events, necessitating surgery in one and clip closure in two.A moderate case occurred in one patient with bile peritonitis after eus-ag who required an additional procedure using be-ercp to place an endoscopic nbd.All other events were mild and were successfully managed with conservative treatment.

• Brand Name: FIELDER 18
• Type of Device: ENDOSCOPIC GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 17917732
• MDR Text Key: 325445181
• Report Number: 3003775027-2023-00098
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention