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

Model Number AHW14R104S

Device Problems Flaked (1246); Peeled/Delaminated (1454)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

While using wire to deliver a device, the coating on wire became flaky and peeled off.Wire do no harm.Removed wire for another.No patient injury.Have product -but need to have return authorize # and address to where to return.

• Brand Name: SION BLUE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 13779240
• MDR Text Key: 293539518
• Report Number: 3004718255-2022-00251
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327133012
• UDI-Public: (01)04547327133012(17)240831(10)210904A40A
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2022,03/10/2022

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
• Device Operator: Health Professional
• Device Model Number: AHW14R104S
• Device Catalogue Number: AHW14R104S
• Device Lot Number: 210904A40A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2022
• Distributor Facility Aware Date: 03/10/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1