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

Catalog Number D134721IL

Device Problem Mechanical Jam (2983)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the catheter was reported to be stuck in a deflected position.It was reported that during the operation, catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.On 13-mar-2023, additional information was received indicating the catheter was actually stuck in a deflected position.The knob/piston was unable to be turned and there was no physical damage to the rings or electrodes.Difficulty removing the catheter was reported.A synaptic medical intracardiac introducer sheath set was used with the catheter at the time of incident.

Manufacturer Narrative

On 2-apr-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.(b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the catheter was reported to be stuck in a deflected position.It was reported that during the operation, catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information was received indicating the catheter was actually stuck in a deflected position.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflection within specifications.No deflection issues were observed.No stuck was identified during the analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The stuck 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.The instructions for use contain (ifu) the following warning and precaution: always pull the thumb knob back to straighten the catheter tip before insertion or withdrawal of the catheter.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 ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 19064906
• MDR Text Key: 339670079
• Report Number: 2029046-2024-01159
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134721IL
• Device Lot Number: 31205142L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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: SYNAPTIC MEDICAL INTRACARDIAC SHEATH.