MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per md report when removing guidewire a small fragment broke from the distal edge of the guidwire and dislogded into coronary vasculature, went into a very small vessel within the distal left circumflex artery.Angiographically no flow compromise related to small wire fragment.Lad result very good.Residual stenosis 0%.

• 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: 12110285
• Report Number: 3004718255-2021-00229
• Device Sequence Number: 20037996
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)231130(10)201210A11A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/01/2021
• Report Date (Section F): 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: AGH146000
• Device Lot Number: 201210A11A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR
• Patient Weight: 70
• Date Report Sent to FDA: 07/02/2021