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

Catalog Number D134805

Device Problems Material Protrusion/Extrusion (2979); Positioning Problem (3009)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the device was damaged causing internal component exposure.It was reported that 30 minutes after the catheter use, during ri posterior ablating, the wire broke.The catheter was removed from the patient's body and confirmed that the wire was broken.Additional information received indicated the puller wire was cut inside the catheter and the damage exposed internal components.There were no sharp or lifted rings.There was no difficulty maneuvering the catheter during the withdrawal.There was no patient consequences.

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 ref#: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the device was damaged causing internal component exposure.It was reported that 30 minutes after the catheter use, during ri posterior ablating, the wire broke.The catheter was removed from the patient's body and confirmed that the wire was broken.Additional information received indicated the puller wire was cut inside the catheter and the damage exposed internal components.There were no sharp or lifted rings.There was no difficulty maneuvering the catheter during the withdrawal.There was no patient consequences.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, microscopy examination, and deflection test of the returned device was performed following bwi procedures.Visual analysis revealed that no internal component were exposed.Then a microscopy examination was perform to review the tip in detail and a hole was observed on the pebax's surface without leaving internal parts exposed.The damage could be related to the usage of the device during procedure, however, this cannot be conclusively determined.Deflection test was performed, and the deflection mechanism failed specifications due to the puller wire, curve d, was found broken inside the handle.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.The damage on the pebax's surface could be related with the internal component exposed issue reported by the customer.It should be noted that product failure is multifactorial.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: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the customer reported internal components exposed and hole in the pebax area.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 10-nov-2023, additional information was received indicating there was no resistance and the catheter was not pre-shaped.On 28-nov-2023, 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.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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 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: 18089264
• MDR Text Key: 328491288
• Report Number: 2029046-2023-02573
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31114538L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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: UNKNOWN SL0 10FR SHEATH.; UNK_CARTO VIZIGO SHEATH.