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 Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30898152l number, and no internal action related to the complaint was found during the review.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 71-year-old male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered bradycardia and hypotension requiring biventricular pacemaker biv implantation.It was reported by the bwi representative that while performing a redo maze procedure (a-fib and aflutter) with a right-sided 2 to 1 and 3 to 1 flutter, the patient went bradycardic and hypotensive.The caller stated that after mapping the right atrium with the pentaray catheter, after inferior vena cava (ivc) and superior vena cava (svc) line where they were able to access the right atrium surgically, the physician was touching up a prior cavotricuspid ishmus (cti) line.When the ablation was in the middle of the cti line the patient went from 100-150 bpm to 30 bpm and the blood pressure dropped to a critical level.There was already a right ventricle quad in.The physician tried pacing the ventricle but was getting intermittent capture.The physician inserted the thermocool® smart touch® sf bi-directional navigation catheter in the right ventricle and got consistent capture but the blood pressure remained low.The patient was cardioverted, and after cardioversion, the cs catheter that was already in place was used to start pacing.Along with medication (the bwi representative did not know what medication was used), the blood pressure increased.They decreased the pacing rate to 800 milliseconds.The bwi ablation was aborted at that time.The patient is receiving a biv-icd implant at the time of the call.When the bwi representative left the lab, about an hour later, the patient was stable.Additional information indicated the physician¿s opinion on the cause of this adverse event is that it was patient condition related.The outcome of the adverse event was reported as improved.

• 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: 15944713
• MDR Text Key: 305144666
• Report Number: 2029046-2022-03063
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 30898152L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: SMARTABLATE GENERATOR SPARE-US; UNK_PENTARAY; UNSPECIFIED WEBSTER CS CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male