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

Catalog Number D134804

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

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned device revealed reddish material inside the pebax and a hole on the surface.This could be related to the handling during procedure; however, this cannot be conclusively determined.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit in the tip area.Error 106 could be related to the foreign material observed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the error 106 issue.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer's reported issue of hole in the pebax.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 ¿cardioneuro¿procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that the caller noted that after 90 seconds of the thermocool® smart touch® sf bi-directional navigation catheter inside of the patient, they began receiving high force values on the carto 3 system.The caller noted that they were unable to rezero the catheter.The caller stated that they were near the end of the procedure when the force issues began.The case continued with the force issues unresolved.The caller noted that when the thermocool® smart touch® sf bi-directional navigation catheter was removed from the patient, they noticed blood within the clear, distal tip of the stsf catheter.There was no patient consequence.The customer¿s reported force and blood inside were not considered to be mdr reportable issues since the potential risk that these could cause or contribute to a serious injury or death to the operator or patient is remote.On 22-feb-2024, the bwi pal revealed that a visual inspection of the returned device found a reddish material inside the pebax and a hole on the surface.These findings were reviewed and assessed the issue of a ¿hole¿ in the pebax as an mdr reportable malfunction since the integrity of the device has been compromised.

• 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: 18908858
• MDR Text Key: 337756167
• Report Number: 2029046-2024-00840
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31086034L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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; INTERFACE CABLE; QDOT MICRO, BI, TC, D-F; UNK_NGEN RF GENERATOR