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

Catalog Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

E 1.Initial reporter phone :(b)(6).A picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, char, thrombus clot residues were observed on the tip; however, with the available information, a potential cause cannot be determined a manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-01919 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-01920 for product code d128211 (pentaray nav eco 7fr, d, 2-6-2).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a pentaray nav high-density mapping eco catheter and a burnt substance that might be thrombus adhered to both smart touch sf catheter and pentaray nav sh.After pulmonary vein isolation (pvi), when the catheter was removed from the patient¿s body to change the saline connected to each catheter, thrombus was found to be adhered to the tip electrode.Although there was interference to pentaray nav sh electrode by the ablation catheter during the ablation, no error occurred in either impedance, temperature, or irrigation, so the exact timing of the thrombus formation was unknown.Both events were resolved by replacing the catheters with new ones.The procedure was successfully completed.No adverse patient consequence was reported.The physician noticed the event when the catheter was removed from the patient¿s body.There were no problems with temperature, resistance, nor irrigation.Ablation time did not exceed 60 seconds (per ablation).Ablation time did not exceed 120 seconds (per ablation).Total ablation time is to be confirmed.Whether mean cf value exceeded 25g is to be confirmed.Mean cf value did not exceed 40g.Irrigation setting was within the recommended range.The setting of pre rf time and post rf time: pre 1s, post 2s.The site of the char adhered was the distal side, respectively.Set power is rpv 30w, lpv 40w, ai 400.A smartablate generator was used with parameters in power control mode.Intracardiac echocardiography after the occurrence of thrombus showed no other thrombus.Patient's condition was fine as of (b)(6), at 22:43.Contact force (cf) monitoring methods were dashboard, vector, and visitag.The coloring settings for visitag was tag index.The physician did not provide any comment about the relationship between the event and the product; however, he/she was informed that there were similar events observed with octaray.He/she strongly requests to verify whether the site was completely ablated with thrombus adhered to the catheter.There were no abnormalities prior to or while using the product.

Manufacturer Narrative

Additional information was received on 13-sep-2023.It was reported that the patient did not exhibit any neurological symptoms.The activated clotting time (act) was maintained above 300.Heparinized normal saline was used.A smartablate pump was used.Therefore, the concomitant product section was updated.On 22-sep-2023, the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation, temperature, impedance, and pump test of the returned device were performed following bwi procedures.A microscopic inspection revealed thrombus/clot residues attached to the dome, blocking some of the irrigation holes.A temperature and impedance test were performed, and no impedance values were displayed due to an open circuit in the tip area.Afterward, during the pump test, the device was not irrigating correctly.This failure could be related to the thrombus residues observed in the dome.A manufacturing record evaluation was performed for the finished device 31079946l number, and no internal actions related to the reported complaint condition were identified.Since no impedance values were observed, this failure could be related to the thrombus/clot issue reported by the customer; therefore, the customer complaint was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-01919 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-01920 for product code d128211 (pentaray nav eco 7fr, d, 2-6-2 during an internal review, it was noted that the correct imdr code for this event is coagulation in device or device ingredient (a030202).Therefore, h6.Medical device problem code has been updated.

• 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: 17643726
• MDR Text Key: 322203665
• Report Number: 2029046-2023-01919
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31079946L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR; UNK_SMARTABLATE PUMP