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

Model Number	AGH143391
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Operations performed: 1.U/s-guided bilateral cfa access.2.Bilateral iliac artery pressure measurements.3.Bilateral common iliac artery (cia) angioplasty.4.Right cia stenting (7 x 59 vbx bes).5.Left sfa recanalization.6.Left sfa angioplasty and stenting (5 x 120 abbott supera stents x 2; overlapping in the sfa).7.Attempted recanalization of rle sfa (unsuccessful).8.Bilateral proglide perclose access closure (1 device per side).Implanted devices: 1. gore vbx 7 mm x 59 mm balloon expandable stent in the right cia.2.Abbott supera 5 mm x 120 mm self-expandable stents x 2 in the left sfa.Description: bilateral femoral access performed to allow for aortic and iliac pressure measurements and treatment.Proceeded then with contralateral 7f sheath access, starting with treating the left leg first.Angioplasty of left sfa with 5 mm x 200 mm balloon and 6 x 80 mm balloons before placing 5 mm x 120 mm supera stents x 2 in the left sfa for left sfa occlusion.Moved to right side.Similar access with 7f sheath from the left side.Attempted to cross the r sfa cto, unsuccessful.Complications: tip of the 0.014 wire (0.5 cm long) remained in the patient's right sfa occlusion without concern for embolization or resulting arterial blockage.Otherwise, no complications.

• 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: 15158771
• Report Number: 3004718255-2022-00269
• Device Sequence Number: 17442239
• Product Code: DQX
• UDI-Device Identifier: 04547327058162
• UDI-Public: (01)04547327058162(17)240831(10)210831A111
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/03/2022
• Report Date (Section F): 08/03/2022

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: 08/31/2024
• Device Model Number: AGH143391
• Device Catalogue Number: AGH143391
• Device Lot Number: 210831A111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/19/2022
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Date Report Sent to FDA: 08/03/2022