MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUIDE WIRE

Model Number	AGH146000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Crossed through a double-jailed side branch with intent of protecting it prior to post-dilation.The radio-opaque portion passed into the side branch but i could not advance it further.I then tried to retract the wire (this is all prior to any post-dilation/ballooning of the double-jailed area) and it would not retract.I tried to free it up by passing a 2.0 balloon over it and it would not.Then with gentle pressure i felt the wire give.With further pressure i was able to retrieve the whole wire including the radio-opaque tip.After removing it from the body it was clear it had unraveled.

• Brand Name: PROWATER
• 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: 16940765
• Report Number: 3004718255-2023-00296
• Device Sequence Number: 12606319
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)231130(10)201223A02A
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2023
• Report Date (Section F): 05/16/2023

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: 11/30/2023
• Device Model Number: AGH146000
• Device Catalogue Number: AGH146000
• Device Lot Number: 201223A02A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2023
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/16/2023