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

Model Number D134801

Device Problem Entrapment of Device (1212)

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

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment with excessive manipulation required issue occurred.The ablation catheter got stuck when it entered the branch of the right pulmonary vein (rpv) and became stuck.Finally, the catheter was pulled out by forceful pulling, but the catheter was replaced because there was a possibility that the ablation catheter was stuck due to an abnormality in its tip.Timing occurred during rpv mapping.The issue was resolved by replacing the thermocool® smart touch® sf bi-directional navigation catheter to another new one.The procedure was completed without patient's consequence.Additional information was received.There was no tip damage/broken observed.The physician just suspected a catheter tip problem because the catheter became caught in a blood vessel and could not be removed.There was no lifted or damaged electrodes observed.No picture available.The physician felt difficulty during the withdrawal.But the physician was able to withdraw the catheter finally.There was no detachment of any component.The issue did not result in exposure of any internal catheter components or sharp edges.The swartz sl0, 8.5f sheath introducer was used.The event was assessed as mdr reportable for a medical device entrapment with excessive manipulation required issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 19-may-2023.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.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

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment with excessive manipulation required issue occurred.The ablation catheter got stuck when it entered the branch of the right pulmonary vein (rpv) and became stuck.Finally, the catheter was pulled out by forceful pulling, but the catheter was replaced because there was a possibility that the ablation catheter was stuck due to an abnormality in its tip.Timing occurred during rpv mapping.The issue was resolved by replacing the thermocool® smart touch® sf bi-directional navigation catheter to another new one.The procedure was completed without patient's consequence.Additional information was received.There was no tip damage/broken observed.The physician just suspected a catheter tip problem because the catheter became caught in a blood vessel and could not be removed.There were no lifted or damaged electrodes observed.The physician felt difficulty during the withdrawal.But the physician was able to withdraw the catheter finally.There was no detachment of any component.The issue did not result in exposure of any internal catheter components or sharp edges.The swartz sl0, 8.5f sheath introducer was used.The device evaluation was completed on 24-may-2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, outer diameter (od) test, 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 deflecting within specifications.No deflection issues were observed.Od test was performed and measurements are within specifications.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.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.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).

• 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: 16959328
• MDR Text Key: 315743747
• Report Number: 2029046-2023-01086
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30991500L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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: NON BWI-SWARTZ SLO 8.5F SHEATH.; UNKNOWN BRAND CATHETER.