MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUDIE WIRE

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Initial information reported from hospital as i was not in case.Prowater was inserted in rca, balloon was advanced over prowater, balloon was inflated, deflated, and when balloon was being removed the physician notice wire was fractured, and the distal end of wire was left in rca.This was not removed and plans from notes were the physician would bring patient back several days later for stenting loose wire to arterial wire.

• Brand Name: PROWATER
• Common Device Name: GUDIE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12465565
• Report Number: 3004718255-2021-00237
• Device Sequence Number: 19780221
• Product Code: DQX
• UDI-Device Identifier: 14547327056127
• UDI-Public: (01)14547327056127(17)240131(10)210202A10A
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/07/2021
• Report Date (Section F): 09/13/2021

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: AGH146000
• Device Lot Number: 210202A10A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2021
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2021
• 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: 09/13/2021