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

Catalog Number D134802

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 05/12/2023

Event Type  malfunction  

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 for which biosense webster¿s product analysis lab (pal) identified a microscopic analysis revealed a hole in the pebax exposing internal components.It was initially reported that the carto 3 system was displaying inaccurate force readings, the catheter was "flinging off of the screen", and there was blood pooling at the tip of the catheter.There was also an ultrasound magnetic sensor which would resolve when the eco cable was disconnected.The caller confirmed that they were not using ultrasound after the transseptal puncture.The caller stated that they would monitor this issue and call back if needed.To troubleshoot the cable was replaced without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.The customer¿s reported force, visualization and pooled blood in the catheter tip are not considered to be mdr reportable issues since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 10-jul-2023, the bwi pal revealed that a visual inspection of the returned device found a reddish material inside the pebax.A microscopic analysis of the device revealed a hole in the pebax exposing internal components.These findings were reviewed and determined the issue of a hole in the pebax is an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax.No other anomalies were observed.A screening test was performed and the device was recognized correctly; however, errors 105 and 106 appeared due to three open circuits in the tip area.The microscopic analysis revealed a hole in the pebax exposing internal components.The root cause of the damage could be related to the handling since in the process as there are control inspection points to avoid these issues.This issue could be contributed to the force issue reported by the customer.The force issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: if force readings might be inaccurate or another catheter is in proximity: an alert message appears, force readings on the dashboard are displayed in gray, and the force graph is colored white.Resolve the issue according to the directions in the alert message to enable force measurement.You can also continue the study without force data.A manufacturing record evaluation was performed for the finished device, and no internal actions was found during the review.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the issue of hole in the pebax.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer's reported issues of force and visualization.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: 17470953
• MDR Text Key: 320692663
• Report Number: 2029046-2023-01709
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• 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: Other
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134802
• Device Lot Number: 30970870L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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; UNSPECIFIED ECO CABLE