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); Appropriate Term/Code Not Available (3191)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

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 reference number: (b)(4).

Event Description

It was reported that a male patient underwent an afib ¿ paroxysmal procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and the procedure was aborted when a thrombus was identified.It was reported that while in the right atrium at the beginning of the case, the physician noted that the initial act was low, 86 or 87.A bolus of heparin was administered, act was then 230 or 260.Mapping was performed with the ablation catheter in the right atrium.While the versacross was being positioned to gain transseptal access, a large clot was noted via ice imaging.The physician used a "technique" to remove all equipment and the clot was no longer seen.The procedure was then aborted- no ablation had been performed.The patient is being monitored for any effects.No harm to the patient as of right now.Two stsf were used.Intervention provided was that the physician inserted a larger french-size sheath to capture and enclosed transeptal apparatus, and pulled it from the groin.Physician reported to that the patient recovered, and experienced no symptoms from the thrombus.Unknown if they were discharged.Further information: the medical team did not go transseptal, the thrombus was seen on the transeptal sheath (baylis versacross) while maneuvering toward tsp.One was used to collect a bit of matrix before realizing it was not displaying impedance.The other was then used and the issue was resolved.Physician commented that patient was continuously on xarelto, and still came into the lab with a baseline act of 87.After two bolus of heparin the patient still only had 270 act, and physician mentioned that the patient may be malignant with cancer, based on the patient¿s resistance to anticoagulation and history of cancer.Thrombus is mdr-reportable.

Manufacturer Narrative

On 25-aug-2023, the product investigation was completed.It was reported that a male patient underwent an afib ¿ paroxysmal procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and the procedure was aborted when a thrombus was identified.It was reported that while in the right atrium at the beginning of the case, the physician noted that the initial activated clotting time (act) was low, 86 or 87.A bolus of heparin was administered, act was then 230 or 260.Mapping was performed with the ablation catheter in the right atrium.While the versacross was being positioned to gain transseptal access, a large clot was noted via intracardiac echocardiography (ice) imaging.The physician used a "technique" to remove all equipment and the clot was no longer seen.The procedure was then aborted- no ablation had been performed.The patient was monitored for any effects.No harm to the patient was reported as of right now.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no thrombus/clot residues were observed.The device features were reviewed, and the device was irrigating properly; however, during the analysis, no impedance was displayed on the screen due to an open circuit in the connector area.A manufacturing record evaluation was performed for the finished device 31060798l number, and no internal actions related to the complaint was found during the review.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Physician¿s opinion on the cause of this adverse event was possibly cancer-related, due to patient's history of cancer and low act despite heparin administration 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.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 reference number: (b)(4).

Manufacturer Narrative

On 18-aug-2023, the bwi product analysis lab received the device for evaluation.The 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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17416929
• MDR Text Key: 320507267
• Report Number: 2029046-2023-01625
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• 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: 31060798L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2023
• 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; SOUNDSTAR CATHETER; THERMOCOOL SMARTTOUCH; VIZIGO SHEATH; WEBSTER CS CATHETER