MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. FIELDER XT; PTCA GUIDE WIRE

Catalog Number	AGP140302
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site: (b)(4).Registration number: (b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.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 referring to known similar events, it was presumed that friction between the guide wire and heavily calcified lesion had most likely contributed to the tearing of the polymer jacket.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [malfunction and adverse effects] abrasion of the guide wire coating.
Event or Problem Description
It was reported that an asahi fielder xt was used in a plain old balloon angioplasty (poba) to treat a mildly tortuous, heavily calcified 90%-99% stenosis in the posterior tibial artery.During the procedure, about 16cm of its polymer jacket came off in the posterior tibial artery and was retained in the calcified lesion.A snare was used to retrieve the peeled polymer jacket, but the attempt was ended unsuccessfully.The patient was finally sent to surgery and they were able to retrieve almost everything but left some foreign body behind.The patient was reportedly fine after the procedure.

• Brand Name: FIELDER XT
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12317300
• Report Number: 3003775027-2021-00143
• Device Sequence Number: 14487379
• Product Code: DQX
• UDI-Device Identifier: 04547327072861
• UDI-Public: (01)04547327072861(17)240229(10)210315A371
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: AGP140302
• Device Lot Number: 210315A371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability