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

Device Problem Insufficient Information (3190)

Patient Problem Sepsis (2067)

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 devices were discarded and not returned from the user facility.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.No mention was made in the literature that the asahi fielder 18 guide wire was involved in the reported adverse events.Referring to known similar events, it was presumed that patient anatomy and procedural contents were most likely associated with such adverse events as cholangitis and sepsis that had occurred during this study.It was concluded that this event was not attributed to product quality.Capa: no capa will be taken.The instructions for use (ifu) states: [warnings] observe 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.[malfunction and adverse effects] infection, cholangitis.

Event Description

It was reported through literature that asahi fielder 18 guide wire might have caused or contributed to cholangitis and/or sepsis.Publication: surgical endoscopy (2022) 36:9001-9010.Title: a novel endoscopic technique using fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy: the saddle-cross technique.Excerpts are as follows: [summary] background: this study aimed to assess the efficacy and safety of the new saddle-cross technique, which uses two fully covered self-expandable metallic stents.Methods: this was a retrospective analysis of 20 patients with benign hepaticojejunostomy anastomotic strictures who underwent placement of two fully covered self-expandable metallic stents at the national cancer center, japan, from november 2017 to june 2021.Results: procedure-related early adverse events included mild ascending cholangitis in three patients (15.0%) and sepsis in one patient (5.0%).In cases of cholangitis and sepsis, contrast enhanced-ct findings were not suggestive of any obstruction and the clinical condition improved with antibiotic treatment.Procedure-related late adverse events included mild ascending cholangitis in three patients (15.0%) and bile duct hyperplasia in one patient (5.0%).Cases of cholangitis improved with antibiotic treatment.Bile duct hyperplasia occurred in the patient whose fc-semss were removed after 334 days; however, no additional treatment was required, and no other adverse events were noted.[treatment strategy] after reaching the hjas, cannulation was performed using a catheter (tandem xl triple lumen ercp cannula; boston scientific, us) and a 0.025-inch hydrophilic guidewire (m-through; marketed by medico's hirata, japan; manufactured and marketed by asahi intecc, japan).In patients with severe strictures, the 0.025-inch hydrophilic guidewire was inserted before cannulation.[saddle-cross technique] in some cases, the delivery system for the fc-semss does not pass through the working channel while the two guidewires are placed when using an enteroscope.In such patients, one fc-sems is placed using the enteroscope, and another is inserted through the guidewire, which passes between the previously placed fc-sems and the anastomosis.Alternatively, if a 0.018-inch guidewire (fielder 18; marketed by olympus, japan; manufactured and marketed by asahi intecc, japan) is used as a guidewire, the delivery system can be inserted while leaving the guidewire.

• 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: yukimi nagumo ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 18966670
• MDR Text Key: 338434640
• Report Number: 3003775027-2024-00037
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

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: 03/14/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Life Threatening