MAUDE Adverse Event Report: ASAHI INTECC SION BLUE; GUIDE WIRE

Model Number	AHW14R104S
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elderly female with history of hypertension (htn) and atrial fibrillation,takes coumadin,and resent chest pain, shortness of breath and positive stress test.Procedure: percutaneous coronary intervention (pci) with rotoblation to right coronary artery (rca).The sion blue wire broke and uncoiled inside the patient in the distal rca.Wire was removed intact, echocardiogram (echo) performed and identified a small perforation to a small vessel which sealed on its own.Patient held in the unit for 30 minutes for observation then transferred to the floor.Additional echo done the same evening with no new findings and confirmed normal.No known further harm to the patient.Used a 1.5 over the wire balloon to exchange the rotofloppy wire for the sion blue wire.During this process, the products came out of the vessel and into the guide causing us to rewire the vessel.While using the sion blue to rewire the vessel, the wire prolapsed and was advanced to the distal part of the rca; noticing that the wire looked mangled in the pda, we did a contrast injection and noticed dye staining in the mid rca.We began ballooning the vessel and continued with the intervention while calling for a stat echo to check for pericardial effusion.Upon their arrival, the echo was done and determined to not have any fluid in the pericardium, so we placed 2 stents.The dye was still present angiographically, so the wire and guide were removed from the vessel and a final echo was done and confirmed normal.The patient was held in the unit for 30 min to ensure no decompensation and then transferred back to the unit with a repeat echo ordered for later that night to ensure no pericardial fluid present.Stat echo, repeat echo, overnight stay for observation.

• Brand Name: SION BLUE
• 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: 13934989
• Report Number: 3004718255-2022-00253
• Device Sequence Number: 4886815
• Product Code: DQX
• UDI-Device Identifier: 04547327133012
• UDI-Public: (01)04547327133012(17)241031(10)211109A36A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/21/2022
• Report Date (Section F): 03/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: AHW14R104S
• Device Catalogue Number: AHW14R104S
• Device Lot Number: 211109A36A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/21/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Date Report Sent to FDA: 03/28/2022