MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Cto of rca mid to distal.After awe with corsair pro (prowater to cap, fielder xt, mongo, gaia, crossed lesion) swapped back to workhorse wire (prowater).Tip of prowater caught very tiny distal branch and was trapper for a second.Physician retracted wire and the wire began to unravel.Physician was able to remove trap most of the fragment with microcatheter and remove wire and some wire gragment.Confirmed with invus and oct that there was not a wire fragment in main vessel, only small amount in tiny branch visual by angiography.Oct confirmed main rca/pda were find and we finished the case by stenting over new prowater wire.Patient was fine.Cto opened.

• 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: 11675292
• Report Number: 3004718255-2021-00213
• Device Sequence Number: 4433584
• Product Code: DQX
• UDI-Device Identifier: 04547327056182
• UDI-Public: (01)04547327056182(17)231231(10)210104A53A
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/08/2021
• Report Date (Section F): 04/15/2021

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: AGH146000J
• Device Lot Number: 210104A53A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2021
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2021
• 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: 04/15/2021