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

Model Number	AGP140302
Health Effect - Clinical Codes	Occlusion (1984); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Totally occluded left distal peroneal was seen on angiogram after normal access.It was determined that the vessel was 100% occluded and that the physician would attempt to intervene.After directing the wire and micro catheter to the proximal cap of the lesion, multiple attempts were made to traverse the co cap after which the wire and micro catheter became lodged in the calcific burden.Multiple attempts were made to withdraw the wire and micro catheter at which time the tip of the micro catheter and wire detached in the calcific cap.The remaining micro catheter and wire were removed and a snare was used to attempt to retrieve the wire and micro catheter tips at which time the loop of the snare became lodged and broke off in the calcium as well.It was determined at that time to stop the case and the physician went to discuss what occurred with the patients family members.

• Brand Name: FIELDER XT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 8858476
• Report Number: 3004718255-2019-00113
• Device Sequence Number: 10840555
• Product Code: DQX
• UDI-Device Identifier: 04547327072861
• UDI-Public: (01)04547327072861(17)220331(10)190415A031
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019
• Report Date (Section F): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: AGP140302
• Device Catalogue Number: AGP140302
• Device Lot Number: 190415A031
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/30/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1