MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient experienced vasospasm during pci of rca causing a myocardial infarction.The prowater wire became trapped when the vessel spasmed, difficulty was noted when attempting to remove the wire from the spasmed vessel, and upon removal it was noted that the distal portion of the wire (spring coil) became elongated.Please refer to the attached picture of the prowater wire after it was removed from the body.Please note that this incident occurred on (b)(6) 2020.I tried to submit the incident at that time, but when the physician reached out to me on (b)(6) 2021 i noticed that i had no record of the incident report in my email potentially due to the volatility of the email servers during that time period.The physician is requesting an analysis report.

• 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: 11569264
• Report Number: 3004718255-2020-00207
• Device Sequence Number: 19885361
• Product Code: DQX
• UDI-Device Identifier: 04547327056182
• UDI-Public: (01)04547327056182(17)230630(10)200709A58A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/10/2020
• Report Date (Section F): 03/25/2021

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: AGH146000J
• Device Lot Number: 200709A58A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68
• Date Report Sent to FDA: 03/25/2021