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	01/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Complex calcified lesion.Ballooned, rotablade, stent.Prowater used during ballooning and stenting.Disection plane distal to distal stent.Upon the third insertion, the wire was shaped with an extra 'j" the wire ended up trapped in an rv marginal.Tried to remove with corsair.Wire frayed and seperated.Tried snare.Patient sent to or.Patient doing well.

• 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: 11478059
• Report Number: 3004718255-2021-00204
• Device Sequence Number: 14310368
• Product Code: DQX
• UDI-Device Identifier: 04547327056144
• UDI-Public: (01)04547327056144(17)211231(10)190122A071
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/24/2021
• Report Date (Section F): 03/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: AGH146300
• Device Lot Number: 190122A071
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2021
• Device Age: 25 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2021
• 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: 79 YR
• Date Report Sent to FDA: 03/12/2021