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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 premature ventricular contraction (pvc) ablation with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the patient experienced heart block that required temporary pacemaker insertion.At the time of pvc procedure, cardiac block occurred by ablating the area adjacent to his.Right ventricular outflow tract (rvot) was mapped.A pvc was diagnosed adjacent to his on the posterior side of rvot.Due to the his electric potentials etc.Could not be seen on the stsf catheter, ablation was done at 30 ~ 35 watts.No abnormalities in conduction were observed, so about 10 sessions of ablation were done.Pvc was suppressed by ablating and the treatment effect was observed.However, ablating was performed again due to pvc recurrence over time.At the time of 13th session of ablation from the room entry, cardiac block was confirmed.Before and after ablating, no product error and no abnormalities in contact force (cf), temperature, ¿and so on¿.Could be found.Though ablating was immediately stopped, the patient had atrioventricular block.Immediately after, a right ventricular (rv) pacing was performed.The patient was observed and since there was no improvement during the procedure, a temporary pacemaker was placed, and the patient left the room.After exiting the room, the patient was followed up about 24 hours to see if conduction will be restored.The patient¿s condition has improved.No abnormalities in products were found but the ablation catheter used on that day is reported.Lot number is unknown pending confirmation.

Manufacturer Narrative

On 01-feb-2024, additional information was received and the lot number was provided.On 04-feb-2024, additional information was received.During the postoperative observation, the atrioventricular block did not improve, so a permanent pacemaker was implanted.The hospitalization was extended for 5 days for observation.Therefore, h6.Health effect - impact code has been updated with the code of hospitalization or prolonged hospitalization (f08).Relevant medical history is preoperative left bundle branch block.The physician¿s opinion on the cause of this adverse event was that it was procedure related.A-h block occurred by ablation.No causal relationship between the event and the product.Smartablate generator was used.Therefore, the concomitant product section was updated.The physician¿s name was provided.Therefore, section e.Initial reporter was updated.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: 18616717
• MDR Text Key: 334256249
• Report Number: 2029046-2024-00360
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31156451L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• 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: SMARTABLATE GEN. KIT (JAPAN); UNK_CARTO 3
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male