MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Vasoconstriction (2126); Ischemic Heart Disease (2493)

Event Date 06/09/2023

Event Type  Injury  

Manufacturer Narrative

On 30-jun-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered an arterial spasm and electrocardiogram st segment elevation requiring medicinal intervention.It was reported that they were performing a cavotricuspid ishmus (cti) line, and while on ablation they lost force, the catheter would flash in and off the screen, and they received an error 401: "map points cannot be acquired." they reported that it looked as though it was in the sheath when it was not.To troubleshoot they swapped out the grounding pad without resolution.The caller was about to replace the cable, but they completed the cti line portion of the procedure, and no further troubleshooting was performed.The issue remains unresolved.They also reported that during the same procedure, they went to map the left atrium, went transeptal, got the sheath over to the left, brought up the reprocessed pentaray catheter, and received an error 116: 20-pole a magnetic sensor error when the catheter was connected to the patient interface unit.They reported that as this was occurring there was st-elevation on the 12-lead ecg.They reported that they performed an angiogram to check the coronary.There was no blockage, and they did not stint.They also checked for effusion and determined that there was none.The st levels then came down.The physician believed that while ablating on the cti line, there was an right coronary artery (rca) spasm which probably came from delayed heating from when they completed the ablation and went to the left side.The patient was stable.They completed the ablation procedure.The anesthesiologist was providing some type of medication intervention, however, the bwi representative was unclear as to what.The adverse event was confirmed using an angiogram and they saw the rca under the cti on intracardiac echocardiography (ice).They reported no further patient symptoms and no further intervention.Additional information received indicated no vizigo sheath was used.The adverse event was discovered during use of the carto 3 mapping system.Physician¿s opinion on the cause of this adverse event is that it was certain procedure related; nothing about bwi product malfunction.Physician performed an angiogram to determine if an artery was occluded, after finding that no arteries were occluded, the physician finished the afib ablation.The patient¿s outcome from the adverse event is fully recovered.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered an arterial spasm and electrocardiogram st segment elevation requiring medicinal intervention.During the procedure, they went to map the left atrium, went transeptal, got the sheath over to the left, brought up the reprocessed pentaray catheter, and received an error 116: 20-pole a magnetic sensor error when the catheter was connected to the patient interface unit.They reported that as this was occurring there was st-elevation on the 12-lead ecg.They reported that they performed an angiogram to check the coronary.There was no blockage, and they did not stint.They also checked for effusion and determined that there was none.The st levels then came down.The physician believed that while ablating on the cti line, there was an right coronary artery (rca) spasm which probably came from delayed heating from when they completed the ablation and went to the left side.The patient was stable.They completed the ablation procedure.The anesthesiologist was providing some type of medication intervention, however, the bwi representative was unclear as to what.The adverse event was confirmed using an angiogram and they saw the rca under the cti on intracardiac echocardiography (ice).They reported no further patient symptoms and no further intervention.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The physician¿s opinion on the cause of this adverse event was that it can happen during that certain procedure; nothing about bwi product malfunction.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17281637
• MDR Text Key: 318645886
• Report Number: 2029046-2023-01464
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31049655L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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: CARTO 3 SYSTEM; REPROCESSED PENTARAY CATHETER; SMARTABLATE PUMP KIT-US; UNKNOWN GROUNDING PAD; UNKNOWN SHEATH; UNSPECIFIED BIOSENSE QUAD CATHETER
• Patient Outcome(s): Required Intervention