MAUDE Adverse Event Report: THEROX INC SSO2 CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SSO2 - 4.0

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

Patient Problem Angina (1710)

Event Date 09/21/2022

Event Type  Injury  

Event Description

A 56-year-old male caucasian patient (height-5.10' and weight-170 lbs.) developed severe substernal chest discomfort radiating in both arms, associated with dyspnea, nausea, and diaphoresis.The patient was moved to the emergency department and diagnosed with acute st-elevated anterolateral myocardial infarction.The pulse was 66 and regular, respiratory rate was 20, and blood pressure was 132/76 mm hg.The patient was immediately brought to the cath lab for coronary angiography and intervention.The patient reported that he had been off his medications and had taken none.The past medical history was significant for hypertension and tobacco addiction.The patient had severe single vessel disease involving proximal lad (left anterior descending artery) and underwent successful angiojet thrombectomy followed by onyx des (drug-eluting stents) placement in proximal lad.A culprit lesion was noted, which is 80% thrombotic stenosis in the proximal left anterior descending third portion of the vessel, 15 mm in length.An anomalous origin of rca (right coronary artery) was noticed.Circumflex arises anomalously from the proximal rca.The physician commented that the patient's anatomy was slightly unusual because the circumflex artery branched off the rca instead of the lad.Hence, the left main was a straight path into the lad.Left heart ejection fraction was 45%, and the apical segment was hypokinetic.Coronary artery spasm was induced, and the guidewire crossing was successful.Angiojet was utilized to remove the clot.A zotarolimus-eluting stent was deployed.Following the intervention, there was a 0% residual stenosis.There was timi (thrombolysis in myocardial infarction) flow 2 before and timi flow 3 following the procedure.No vessel dissection was noted, with an excellent angiographic appearance.The patient experienced mild lv (left ventricle) dysfunction.After clot removal with angiojet and successful pci (percutaneous coronary intervention) with stent placement, achieving timi flow 3, the physician set up sso2 therapy and started the infusion.The patient was anticoagulated per standard practice with heparin and aggrastat with an act (activated clotting time) at the start of sso2 of around 250's.The sso2 setup was successful, and there was no difficulty placing the sso2 catheter 4.0.The access point was the right femoral artery.Left heart cath with ventriculogram was performed.Approximately 30 mins into the infusion and immediately after the act draw, the patient reported discomfort, and st elevation was noted.The physician stopped the procedure to perform angiography, which revealed a coronary spasm of the lad.No new thrombus was noted, and the stent was patent.The event of coronary spasm was relieved with intracoronary nitroglycerin.No additional angioplasty or revascularization was performed.The patient was discharged with follow-up recommendations: aspirin and efficient per protocol, continue aggrastat, ntg (nitroglycerin) drips overnight, beta blocker, acei (angiotensin-converting enzyme inhibitor), and statin agent; smoking cessation and cardiac rehab.

Manufacturer Narrative

The sso2 catheter in the reported complaint will not be returned for investigation.No device malfunction was reported on the catheter.The event log data from the therox downstream console used during the reported event was downloaded and reviewed.The event log indicated that the device performed as intended during the event.At 36 minutes, the patient had discomfort; the physician disconnected the catheter for imaging of the artery.The downstream console detected the disconnection and stopped treatment momentarily.Treatment was restarted, but at 40 minutes, the treatment was stopped by the physician because of the coronary spasm.The event was serious as event required the administration of intracoronary nitroglycerin.The event of coronary artery spasm was possibly related to the usage of the sso2 device based on relevant timing and location.At the same time, the patient's clinical condition probably contributed to the event as well.Two confounders reported in relation to this event were odd anatomy as the circumflex artery branched off of the rca instead of the lad, so the left main was a straight path into the lad.It seems that the patient was predisposed to spasms as already experienced spasms during the pci procedure.Also unusual was the use of angiojet during the case prior to infusion, which could predispose the artery to a consequence spasm during the sso2 procedure.The event is anticipated and is "possibly" related to the device and procedure.

• Brand Name: SSO2 CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): THEROX INC; 17500 cartwright rd; 100; irvine CA 92614
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15612902
• MDR Text Key: 301821523
• Report Number: 2030964-2022-00006
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00862478000438
• UDI-Public: 00862478000438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SSO2 - 4.0
• Device Catalogue Number: 90040-0001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 77 KG