MAUDE Adverse Event Report: ASAHI INTECC GRAND SLAM; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Stenosis (2263); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Date of Event	05/27/2021
Type of Reportable Event	Death
Event or Problem Description
Description of what occurred intra-procedurally, found high-grade distal left main into ostial lcx stenosis, treated with rotational atherectomy, pci and stent of the left main into lcx.Complicated by wire perforation and small pericardial effusion, treated with balloon tamponade.While balloon was up, patient became hypotensive and eventually pea arrest requiring chest compressions.Pericardial drain placed empirically without improvement, then impella placed but there was difficulty inserting impella due to severe iliac disease, treated with balloon angioplasty and eventual impella placement, however during this time had vf refractory to shock.Another drain was placed during rounds of cpr but was actually placed in lv.Access of r femoral was not possible due to chronic occlusion, so r brachial access obtained.Angiography revealed thrombosed left main, opened into lad but could not open lcx.Temp pacer placed due to intermittent sinus with block/vt/vf.After discussion with family, decided to withdraw care.
Event or Problem Description
Description of what occurred intra-procedurally, found high-grade distal left main into ostial lcx stenosis, treated with rotational atherectomy, pci and stent of the left main into lcx.Complicated by wire perforation and small pericardial effusion, treated with balloon tamponade.While balloon was up, patient became hypotensive and eventually pea arrest requiring chest compressions.Pericardial drain placed empirically without improvement, then impella placed but there was difficulty inserting impella due to severe iliac disease, treated with balloon angioplasty and eventual impella placement, however during this time had vf refractory to shock.Another drain was placed during rounds of cpr but was actually placed in lv.Access of r femoral was not possible due to chronic occlusion, so r brachial access obtained.Angiography revealed thrombosed left main, opened into lad but could not open lcx.Temp pacer placed due to intermittent sinus with block/vt/vf.After discussion with family, decided to withdraw care.Performed rotational atherectomy of the left main into the lcx with rota floppy wire in the om1.Rotablator removed and wire exchanged over corsair for grand slam.Multiple balloon inflations of the left main and om1 over this and attempted to place stents in the om but unsuccessful.Stent placed left main into proximal left circumflex with good result.I pulled grand slam back after stent was delivered to take an angiogram but noticed the floppy part had separated.Angiography at this point revealed a large perforation of the distal om into the pericardium.

• Brand Name: GRAND SLAM
• 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: 11940201
• Report Number: 3004718255-2021-00221
• Device Sequence Number: 17000959
• Product Code: DQX
• UDI-Device Identifier: 04547327055833
• UDI-Public: (01)04547327055833(17)220531(10)190601A141
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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,Followup
• Report Date (Section B): 06/01/2021
• Report Date (Section F): 06/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: AG141002
• Device Lot Number: 190601A141
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/01/2021
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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: Death
• Patient Age: 77 YR
• Date Report Sent to FDA: 06/04/2021