MAUDE Adverse Event Report: ASAHI INTECC CONFIANZA PRO 12; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Narrative from staff: while performing a cto pci (chronic total occlusion) in the cath lab an interventional wire was advanced (cp12) retrograde from the lad {left anterior descending artery) into the rca (right coronary artery) and attempted to break through the occlusion.The decision to exchange wires was made and upon trying to pull back the wire it appeared to be "stuck".After some thought and a second doctors consult there was nothing to do other then pull it back.The wire unraveled and broke apart leaving the distal tip of the wire in the rca and some of the unraveled wire all the way back through into the left system.We stented the left main and lad pinching the wire between the vessel and the stent so that it would not go anywhere.Other equipment in the body at the time was a 7f ebu 4.0 and a 150mm caravel microcatheter.

• Brand Name: CONFIANZA PRO 12
• 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: 11823297
• Report Number: 3004718255-2021-00217
• Device Sequence Number: 17065195
• Product Code: DQX
• UDI-Device Identifier: 14547327058152
• UDI-Public: (01)14547327058152(17)221231(10)191224A10A
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2021
• Report Date (Section F): 05/13/2021

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: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: AGH143091
• Device Lot Number: 191224A10A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2021
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 110
• Date Report Sent to FDA: 05/13/2021