MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6 ST+ JL3.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 533618

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

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Cardiogenic Shock (2262)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported from the hospital, a physician identified bubbles located in the coronary artery after the first coronary catheterization, with the use of the 6f judkin's left 3.5 x 100cm super torque plus diagnostic catheter.This issue provoked an unexpected deterioration of the patient's health.The device was used to inject contrast inside the coronary artery during the catheterization procedure.After the device had been connected with the injection system, the physician performed the procedure to remove bubbles from the device.Then, the physician carried out all initial tests to visualize the catheter, with the purpose to evaluate the ratio between the catheter and the left coronary sinus.Before injecting into the coronary artery, the physician performed tests to check the catheter position in relation to the ostium of the coronary artery.Three injections were performed with the catheter.Bubbles were appreciated during the 4th injection.The patient went into cardiac arrest for a few seconds after the bubbles were injected.Immediately after this event, advanced cardiac life support (acls) was performed.At the same time, the physician performed percutaneous coronary intervention (pci) on the 99% stenotic lad.At the end of the procedure, the physician implanted an intra-aortic balloon pump (iabp).The patient fell into cardiogenic shock; however, the patient is now safe.There was no malfunction of the device itself, aside from the serious injury incurred.A contralateral approach was not used.The lesion was simple; there was no calcification, acute angulation or bifurcation.There was 99% of stenosis of the mid left anterior descending artery (lad).There were no anomalies noted with the catheter.Prior to use, the catheter was flushed with a ¿physiological¿ solution and heparin.The patient received an injection of 2500u of heparin prior to diagnostic catheterization.The patient did not have any underlying medical conditions, which may be related to the reported event.The catheter was forcibly aspirated and flushed with heparinized saline at least once every two minutes.Due to the event that the patient underwent, the patient was in the intensive care unit (icu) for a few days.The device will be returned for evaluation.

Event Description

As reported from the hospital, a physician identified bubbles located in the coronary artery after the first coronary catheterization, with the use of the 6f judkin's left 3.5 x 100cm super torque plus diagnostic catheter.This issue provoked an unexpected deterioration of the patient's health.The device was used to inject contrast inside the coronary artery during the catheterization procedure.After the device had been connected with the injection system, the physician performed the procedure to remove bubbles from the device.Then, the physician carried out all initial tests to visualize the catheter, with the purpose to evaluate the ratio between the catheter and the left coronary sinus.Before injecting into the coronary artery, the physician performed tests to check the catheter position in relation to the ostium of the coronary artery.Three injections were performed with the catheter.Bubbles were appreciated during the 4th injection.The patient went into cardiac arrest for a few seconds after the bubbles were injected.Immediately after this event, advanced cardiac life support (acls) was performed.At the same time, the physician performed percutaneous coronary intervention (pci) on the 99% stenotic lad.At the end of the procedure, the physician implanted an intra-aortic balloon pump (iabp).The patient fell into cardiogenic shock; however, the patient is now safe.There was no malfunction of the device itself, aside from the serious injury incurred.A contralateral approach was not used.The lesion was simple; there was no calcification, acute angulation or bifurcation.There was 99% of stenosis of the mid left anterior descending artery (lad).There were no anomalies noted with the catheter.Prior to use, the catheter was flushed with a ¿physiological¿ solution and heparin.The patient received an injection of 2500u of heparin prior to diagnostic catheterization.The patient did not have any underlying medical conditions, which may be related to the reported event.The catheter was forcibly aspirated and flushed with heparinized saline at least once every two minutes.Due to the event that the patient underwent, the patient was in the intensive care unit (icu) for a few days.The device was not returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, d8, g3, g6, h1, h2, h6, and h10 complaint conclusion: as reported from the hospital, a physician identified bubbles located in the coronary artery after the first coronary catheterization, with the use of the 6f judkin's left 3.5 x 100cm super torque plus diagnostic catheter.This issue provoked an unexpected deterioration of the patient's health.The device was used to inject contrast inside the coronary artery during the catheterization procedure.After the device had been connected with the injection system, the physician performed the procedure to remove bubbles from the device.Then, the physician carried out all initial tests to visualize the catheter, with the purpose to evaluate the ratio between the catheter and the left coronary sinus.Before injecting into the coronary artery, the physician performed tests to check the catheter position in relation to the ostium of the coronary artery.Three injections were performed with the catheter.Bubbles were appreciated during the 4th injection.The patient went into cardiac arrest for a few seconds after the bubbles were injected.Immediately after this event, advanced cardiac life support (acls) was performed.At the same time, the physician performed percutaneous coronary intervention (pci) on the 99% stenotic lad.At the end of the procedure, the physician implanted an intra-aortic balloon pump (iabp).The patient fell into cardiogenic shock; however, the patient is now safe.There was no malfunction of the device itself, aside from the serious injury incurred.A contralateral approach was not used.The lesion was simple; there was no calcification, acute angulation or bifurcation.There was 99% of stenosis of the mid left anterior descending artery (lad).There were no anomalies noted with the catheter.Prior to use, the catheter was flushed with a ¿physiological¿ solution and heparin.The patient received an injection of 2500u of heparin prior to diagnostic catheterization.The patient did not have any underlying medical conditions, which may be related to the reported event.The catheter was forcibly aspirated and flushed with heparinized saline at least once every two minutes.Due to the event that the patient underwent, the patient was in the intensive care unit (icu) for a few days.The product was not returned for analysis.A product history record (phr) review of lot 18142339 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿air embolism, cardiac arrest and cardiogenic shock¿ could not be confirmed without the return of the device.Additionally, a product malfunction was not reported, and procedural films were not provided.Air embolism is a known potential adverse event associated with performing coronary angiograms and are almost always iatrogenic in nature and can be prevented with proper caution used to ensure that air is removed from the system prior to injecting.In this particular situation three injections were performed without incident, suggesting that on the fourth injection, there may have been residual air in the power injector syringe that was not completely expunged.Coronary air embolism can be asymptomatic or cause chest pain, st-segment elevation myocardial infarction, arrythmias, hypotension and death.It is unclear in the reported sequence of events when the patient went into cardiogenic shock.The indication for the heart catheterization was also not reported.Cardiogenic shock is a well-known complication associated with anterior wall myocardial infarctions due to a stenosed left anterior descending artery.Based on the information available for review, patient, concomitant device(s) and/or handling factors may have contributed to the reported events.Air embolism is a potential adverse event associated with angiographic catheters and is listed in the ifu as such.According to the instructions for use: ¿before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ if the user is unable to properly remove air from the device, or properly connect the luer hub to a syringe, the user is trained to determine cause and/or exchange devices.Neither the dhr review nor the information provided suggests that the events experienced by the customer could be related to the manufacturing process.Therefore, no corrective/preventive actions will be taken at this time.

• Brand Name: CATH F6 ST+ JL3.5 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16080568
• MDR Text Key: 306495708
• Report Number: 9616099-2022-06198
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 533618
• Device Catalogue Number: 533618
• Device Lot Number: 18142339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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
• Treatment: AVA500PEDL 86600153 SET AVA500MPAT (BAYER) SETAVA
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 80 YR