MAUDE Adverse Event Report: ASAHI INTECC SION BLACK; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Sion black had been used to navigate down the at distal to the foot and performed well until it was being removed.The sion black was being removed with a navicross.014" 150cm curved tip and became stuck near the hub, they swapped the.014" navi for an.018" 150cm navicross and device was still not easily able to be removed.Once the sion black was removed from the anatomy it was examined and the coating had been compromised and appeared to have been stripped down the metal in an accordion fashion in the distal 10-30cm area.They were able to angiographically confirm that no coating was left in the anatomy and there was no harm tot he patient.They do have the sample of the device that i will be picking up and sending in next tuesday, as well as a couple picture that i have attached.

• Brand Name: SION BLACK
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 11864132
• Report Number: 3004718255-2021-00218
• Device Sequence Number: 19865947
• Product Code: DQX
• UDI-Device Identifier: 04547327089708
• UDI-Public: (01)04547327089708(17)231031(10)201102A271
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2021
• Report Date (Section F): 05/21/2021

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: APW14R310S
• Device Lot Number: 201102A271
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 75
• Date Report Sent to FDA: 05/21/2021