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

Catalog Number D134805

Device Problems Break (1069); Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Rupture (2208)

Event Date 01/19/2024

Event Type  Injury  

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

Event Description

It was reported that a patient underwent an idvt ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced papillary muscle rupture due to catheter getting stuck in the left ventricle of the heart, which caused the tip of the catheter to break inside the patient.During a procedure, an adverse event occurred.While ablating, the catheter got stuck in the left ventricle of the heart.When it was pulled out, it ripped some of the chordae during extraction.The medical team reported that "the tip of the catheter almost snapped in two." the tearing of the tissue was confirmed through a transesophageal echocardiogram.The catheter tip appeared chipped three-quarters of the way through.Once the catheter was pulled out it kept giving high-force readings.No adverse patient symptoms occurred.There was no medical intervention that happened as a result of the catheter damage during extraction.The patient was monitored and was in stable condition.Before the catheter was inserted into the body for the procedure, the force readings were accurate and there did not appear to be damage to the tip.The device damage and force issue were only noted after the catheter was withdrawn.

Manufacturer Narrative

On 4-mar-2024, the product investigation was completed.It was reported that a patient underwent an idvt ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced papillary muscle rupture due to catheter getting stuck in the left ventricle of the heart, which caused the tip of the catheter to break inside the patient.During a procedure, an adverse event occurred.While ablating, the catheter got stuck in the left ventricle of the heart.When it was pulled out, it ripped some of the chordae during extraction.The medical team reported that "the tip of the catheter almost snapped in two." the tearing of the tissue was confirmed through a transesophageal echocardiogram.The catheter tip appeared chipped three-quarters of the way through.Once the catheter was pulled out it kept giving high-force readings.No adverse patient symptoms occurred.There was no medical intervention that happened as a result of the catheter damage during extraction.The patient was monitored and was in stable condition.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual and dimensional inspections and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.A dimensional inspection was performed, and the device passed within specification.The force feature was tested, and the device was recognized and visualized correctly; however, negative force vector appeared in the system with high force readings.A manufacturing record evaluation was performed for the finished device 31185635l, and no internal action was found during the review.The damage on the pebax with reddish material inside, could be related to the force issue and the broken condition reported by the customer.It should be noted that product failure is multifactorial.The root cause of the medical device entrapment and adverse event remains unknown.The instructions for use (ifu) contain the following recommendations: do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.In addition, states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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).

Manufacturer Narrative

On 12-feb-2024, bwi received additional information regarding the event.No surgery or intervention was required.Reporter claimed patient was doing well.There was no sharpening of the catheter tip nor resistance when getting access the e section physician/reporter details have been provided as well.On (b)(6) 2024, the bwi product analysis lab received the device for evaluation.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).

• 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: 18679276
• MDR Text Key: 335035808
• Report Number: 2029046-2024-00448
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31185635L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2023
• 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
• Patient Outcome(s): Other