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

Model Number D134805

Device Problems Complete Blockage (1094); Insufficient Cooling (1130); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 reference number: (b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident, requiring prolonged hospitalization.Catheter temperature rose and electrical current stopped due to impedance rise at the time of left pulmonary vein (lpv) isolation.When it was visually checked outside the heart, thrombus adhesion was found on the catheter tip.The thrombus was adhered to the distal side.Catheter was selected as non irrigation (4 mm) due to human error, and high-flow irrigation was not conducted.The ablation time was not greater than 60 seconds (about 20 ~ 30 s).Ablation time was not greater than 120 seconds.The total energized for this procedure was 40 ~ 60 min.Mean cf did not exceed 25 g and the average cf greater than 40 g was not exceeded.The irritation setting within the specified range was low flow (2cc) irrigation was conducted due to non-irrigation setting.The pre rf time and post rf time set for only low flow (2cc) was pre: 1s, post: 5s.There were no abnormalities observed prior to or during use of the product.Ablation was stopped when cut-off value over.No ablation continued above temperature cut off value.The generator parameters was power 40w.The impedance was exceeded the cut-off value and stop ablation.The system stopped the ablation when it exceeded the cut-off value immediately stop ablation, never continued over the cut-off value.No error message observed.There was no catheter issues related to temperature and flow on the catheter.The generator used was a smartablate generator.The correct catheter settings were not selected on the generator, non-irrigation catheter setting was selected on the generator by human error.The pump was not switching from low to high flow during ablation.Only low flow 2ml/min flowed because of non-irrigation catheter setting was selected.No error observed, but the ablation was stopped because it exceeded the cut-off value.Extended hospitalization was required and cerebral infarction was confirmed.The patient was fully recovered (no residual effects).A transseptal puncture was performed with a rf needle.Prior to noting the cardiac tamponade ablation was performed.There was no evidence of steam pop.The event occurred during ablation phase, after pvi completed.Force visualization features used dashboard; vector; visitag with the visitag module parameters for stability were 2mm, 3sec, 3g, 25%, 2mm with fot and tag index.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 21-sep-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident, requiring prolonged hospitalization.Device evaluation details: visual analysis of the returned product revealed that the catheter was found in normal condition, per the event, several tests were performed.An electrical test was performed, and current leakage was observed, then the catheter was connected to the carto3 system, and the current leakage was confirmed, the flow test was performed, and water leakage was observed inside of the handle, only the deflection test passed.The catheter was open, and it was found that the irrigation tube was found broken causing the water leakage.Also, corrosion on the pins was observed.The root cause of the damage on the shaft could be related to the handling of the device during the shipment however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30794801l number, and no internal action was found during the review.The root cause of the adverse event remains unknown.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15396453
• MDR Text Key: 299663933
• Report Number: 2029046-2022-02176
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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: 30794801L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2022
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; RF TRANSSEPTAL NEEDLE; SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male