MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. MEISTER 16; PERIPHERAL GUIDE WIRE

Catalog Number AMS-180-16STR

Device Problem Peeled/Delaminated (1454)

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

Event Date 07/14/2023

Event Type  Injury  

Event Description

It was reported that an asahi meister guide wire was used during a transcatheter arterial embolization (tae) to treat the segment 8 of the hepatic artery.During the procedure, the meister guide wire could not be manipulated as intended.Upon removal, the wire tip was found deformed.The guide wire was then replaced to resume the procedure.The intended treatment was successfully completed.There were no adverse patient effects associated with this event.

Manufacturer Narrative

Manufacturing site: asahi intecc hanoi co., ltd.Hanoi, vietnam, registration number: 3009121749.When the reported product was returned to the manufacturer, reportable malfunction was recognized for the first time; therefore, g3.Date received by manufacturer is the same as the date in d9.Returned to manufacturer.The reported meister guide wire was returned for evaluation.The returned meister guide wire was found bent at approximately 70mm from the tip.At the bent segment, the coil pitch was found disarranged due to accumulated torsion, peeling the outmost polymer jacket and partially exposing the coil.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 investigation outcome, it was presumed that the bending stress generated with pushing and pulling manipulation might have been locally applied on the meister guide wire due to anatomical conditions.The applied bending stress would have exceeded the product design limit causing the wire tip to be bent.Further applied torsion generated with torquing manipulation would accumulate on the wire tip, disarranging the coil pitch to peel the outermost polymer jacket.It was concluded that this event was not attributed to product quality.Although no adverse patient effects occurred, it was unable to completely rule out a possibility that fragmented polymer jacket might be left in the patient.No capa will be taken.Instructions for use (ifu) states: [warnings]: if this guide wire meets resistance or any anomaly during use, do not continue the manipulation.While paying much attention to possible complications, carefully withdraw the whole system.When torquing the guide wire, rotate it clockwise and counterclockwise alternately.Do not exceed two rotations (720쳌) in the same direction.Observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.[malfunction and adverse effects]: damage.

• Brand Name: MEISTER 16
• Type of Device: PERIPHERAL 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: 17507130
• MDR Text Key: 321065947
• Report Number: 3003775027-2023-00076
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327123266
• UDI-Public: (01)04547327123266(17)251231(10)230105A11A
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161584
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMS-180-16STR
• Device Lot Number: 230105A11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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