MAUDE Adverse Event Report: ASAHI INTECC ASAHI PROWATER; GUIDE WIRE

Catalog Number	AGH146000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The wire was opened and prepped.Placed into the body and the physician noticed the wire didn't look proper on the initial angiography.The wire never engaged the coronary arteries and was removed.Upon removal the wire was inspected and noticed that the mid-portion of the wire appears to have come unraveled.There was no adverse event.A new wire was opened and the case was completed.
Event or Problem Description
The wire was opened and prepped.Placed into the body and the physician noticed the wire didn't look proper on the initial angiography.The wire never engaged the coronary arteries and was removed.Upon removal the wire was inspected and noticed that the mid-portion of the wire appears to have come unraveled.There was no adverse event.A new wire was opened and the case was completed.

• Brand Name: ASAHI PROWATER
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, ja 489-0 071; JA 489-0071
• MDR Report Key: 9344885
• Report Number: 3004718255-2019-00124
• Device Sequence Number: 14136801
• Product Code: DQX
• UDI-Device Identifier: 14547327056127
• UDI-Public: (01)14547327056127(17)220531(10)190610A17A
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019
• Report Date (Section F): 02/13/2020

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: No Information
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: AGH146000
• Device Lot Number: 190610A17A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/13/2020