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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 06/22/2023

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

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced a heart block av requiring pacemaker implantation and prolonged surgical intervention.After the ablation was completed, pacing failure of the pacemaker occurred.Since recovery was not seen, a temporary external pacemaker was placed, and the patient was followed up.Physician's assessment of the health hazard is that it was non-serious (moderate/minor).The patient required prolonged hospitalization.The physician's opinions on the relationship between the event and the product was that it was possible that the rf affected the myocardium at the electrode of the pacemaker, but the causal relationship was unknown.There were no abnormalities observed prior to or during use of the product.The patient had been implanted with pacemaker due to complete atrioventricular block.The adverse event was discovered post use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that radio frequency may have affected on myocardium where the pacemaker electrode was detained.Outcome of the adverse event was reported as improved.Patient required extended hospitalization because of the adverse event.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced a heart block av requiring surgical intervention for pacemaker implantation and prolonged hospitalization.After the ablation was completed, pacing failure of the pacemaker occurred.Since recovery was not seen, a temporary external pacemaker was placed, and the patient was followed up.Physician's assessment of the health hazard is that it was non-serious (moderate/minor).The patient required prolonged hospitalization.The physician's opinions on the relationship between the event and the product was that it was possible that the rf affected the myocardium at the electrode of the pacemaker, but the causal relationship was unknown.Device evaluation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31056119l and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed there was a misstatement in the section b5 of the 3500a initial medwatch.It was incorrectly reported: ¿the patient experienced a heart block av requiring pacemaker implantation and prolonged surgical intervention.¿ the correct statement should have read: ¿the patient experienced a heart block av requiring surgical intervention for pacemaker implantation and prolonged hospitalization.¿.

• 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: 17372588
• MDR Text Key: 319524591
• Report Number: 2029046-2023-01562
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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 Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 31056119L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GEN. KIT (JAPAN); THMCL SMTCH SF BID, TC, D-D
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male