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

Catalog Number D134721IL

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Protrusion/Extrusion (2979); Positioning Problem (3009)

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

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and internal components were exposed.It was reported that during the operation, catheter was unable to deflect or relax completely.Visualization of the device disappeared or was not clear.A second device was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported deflection, visualization and force issues are not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.Additionally, a picture of the complaint device was provided and internal component exposure was observed.This was reviewed and deemed to be an mdr reportable malfunction since the integrity of the device has been compromised.

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.E1: initial reporter facility name: the 988th hospital of the joint logistics support force of the people's liberation army of china.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

On (b)(6) 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.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 flutter ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and internal components were exposed.It was reported that during the operation, catheter was unable to deflect or relax completely.Visualization of the device disappeared or was not clear.A second device was used to complete the operation.There was no adverse event reported on patient.A picture of the complaint device was provided and internal component exposure was observed.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, screening, magnetic sensor functionality, and deflection test were performed following bwi procedures.Visual inspection was performed, and the shaft was observed broken next to the handle.Internal components were observed broken.The device was connected to the carto and several magnetic errors were observed due to the broken internal components.Deflection testing was performed, and the deflection mechanism failed specifications due to the puller wire was broken in the shaft.The damage observed could be caused during removal the catheter after the procedure or the manipulation of the catheter during the procedure, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were confirmed based on the physical and photo analysis.It should be noted that product failure is multifactorial.All issue are directly related to the damage identified in the shaft.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: fracture problem (c070603) / investigation conclusions: cause not established (d15) / component code: steering wire (g04121) were selected as related to the deflection issue.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the internal components that were exposed.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112)were selected as related to the broken shaft near the handle.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the magnetic sensor errors observed during product analysis.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: 18540096
• MDR Text Key: 333485631
• Report Number: 2029046-2024-00218
• 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,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 31151089L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1