MAUDE Adverse Event Report: ASAHI INTECC SION; GUIDE WIRE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

A case report of right ventricular compression from a septal haematoma during retrograde coronary intervention to a chronic total occlusion a case report of right ventricular compression from a septal haematoma during retrograde coronary intervention to a chronic total occlusion" in this case, we describe the formation of a septal haematoma during retrograde cto pci.A (b)(6) woman with hypertension and hyperlipidaemia developed typical angina with an inability to carry any physical activity (canadian cardiovascular society class iv) over a 6-month timeframe.The patient then underwent coronary angiography, which showed a right coronary artery (rca) cto with no other significant epicardial coronary artery disease.Due to her ongoing symptoms and single vessel disease, the decision was made to proceed with cto pci.Due to patient preference to immediately ambulate post-procedure, a biradial approach was chosen for her cto pci.The patient was pre-loaded with aspirin and clopidogrel, and underwent cto pci with a 7-fr al 0.75 guide and a 7-fr ebu 3.5 guide.Dual angiography revealed a mid-rca cto, which was approximately 24 mm in length.The plan was made to proceed with an antegrade approach using heparin with a target activated clotting time (act) of >300 s.An antegrade approach was initially attempted utilizing a turnpike microcatheter and the following guidewires in serial succession: fielder xt-a, pilot 200, and gaia 2nd.However, these wires kept going subintimal and there was also a wire exit with the gaia 2nd wire.The cto strategy was then switched to a retrograde approach utilizing a turnpike 150 cm microcatheter.The act target was now increased to >350 s.A septal collateral to the right posterior descending artery was crossed with the use of a sion wire.A gaia 2nd wire was then used retrograde to successfully cross the cto from the distal true lumen to the proximal true lumen, which was then exchanged for a r350 externalizable wire.Percutaneous coronary intervention was then performed on the externalized wire via standard fashion with an excellent angiographic result.She fared well without any haemodynamic stability or arrhythmias initially in the post-procedural area.

• Brand Name: SION
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 11198401
• MDR Text Key: 227751108
• Report Number: 3004718255-2021-00195
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2021,01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UKN
• Device Lot Number: UKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2021
• Distributor Facility Aware Date: 01/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR