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

Catalog Number E0018450AG-2

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: (b)(4).The reported fielder 18 guide wire was returned for investigation.The returned fielder 18 guide wire was found curved for approximately 2cm from its tip, and its coil pitch was widened at approximately 4.5cm from the tip.At approximately 7.5-8cm and at approximately 255cm from the tip, polytetrafluoroethylene (ptfe) coating and polyether ether ketone (peek) coating were found scraped as deep as to the shaft core, likely caused by contacting a relatively hard and sharp object.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information and the investigation outcome, it was presumed that strong friction was generated on the surface of the subject fielder 18 guide wire when it came in contact with its concomitantly used disposable biopsy needle as resistance increased between the two devices.Consequently, the distal segment of the fielder 18 guide wire was curved, its coil was stretched, and the ptfe and peek coating was damaged.The exposed shaft core segment where the coating was damaged could be recognized as discoloring.It was concluded that this event was not attributed to product quality.However, possibility that some coating fragments might be left in the patient anatomy could not be completely ruled out.Capa: no capa will be taken.The instructions for use (ifu) states: [warnings] - this guide wire is coated with polytetrafluoroethylene (ptfe), polyether ether ketone (peek) and a hydrophilic polymer.Failure to follow the instructions provided under "warnings" and "precautions" may cause damage to the coating, and require medical intervention or lead to severe adverse effects.[precautions] - if abnormal resistance if felt during use of this guide wire, stop the operation immediately.Determine the cause of resistance within the endoscope's field of view or under fluoroscopy, and take any necessary remedial action.- when using this guide wire with a metal needle, operate (push or pull with rotation) only the radiopaque portion at the distal end of this guide wire for not more than 5 times.Operation of the part proximal to the distal radiopaque portion of this guide wire must be limited to pushing.[malfunction and adverse effects] - peeling of coating.

Event Description

It was reported that resistance was met when an asahi fielder 18 guide wire was inserted into an unspecified disposable biopsy needle during an endoscopic ultrasound/ultrasonography-guided biliary drainage (eus-bd).Coating of the guide wire was delaminated, and change in color of the affected segment was observed.An unspecified alternative device was used instead to continue the procedure, and the scheduled drainage was completed.The physician commented that the reported event was attributed to concomitant use of the disposable biopsy needle with the subject fielder 18 guide wire under the recognition that such combination use was not ensured.It was informed that there were no adverse patient effects associated with the event after procedure to this day.

• 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: 19094646
• MDR Text Key: 339982577
• Report Number: 3003775027-2024-00046
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 04547327134248
• UDI-Public: (01)04547327134248(17)260228(10)230208S01B
• 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: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E0018450AG-2
• Device Lot Number: 230208S01B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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