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 07/06/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a heart block.It was reported that there was ablation to the earliest site of atrial tachycardia (at) near his resulted in complete atrioventricular block.At appeared after pulmonary vein isolation (pvi).At was not persistent, so his was first mapped at sinus.Since only one location of his was visible on thermocool® smart touch® sf bi-directional navigation catheter, his tag was created at that point.The cl of the at that appeared after that was around 300-400.Isp was administered, the left atrium was mapped, and the early site on the septal side of the left atrium was ablated, but at was not terminated.The right atrium was mapped, and the septum and annulus area were early like focal at.The ta 6 o'clock direction and csos were ablated, but at was not terminated.Then the fifth at mapping was performed.Although the his wave was not clearly detected during the mapping, the operator voluntarily placed a his tag at one point where a his-like waveform was confirmed, and he/she informed the doctor about it.At the time of the ablation, the view was fixed to rao and lao, the ablation was conducted immediately after confirming the early site with ripple, so the his tag could not be seen clearly before the ablation.His wave was not visible on the ablation catheter before the ablation.After 10 seconds of ablation, av block was confirmed, and hr was secured by pacing with the ablation catheter, and no decrease in blood pressure occurred.A pacemaker was then inserted.The surgeon explained to the patient that a pacemaker implantation would be necessary, and then he/she explained to the patient¿s family.The distance between visitag and his tag was later confirmed to be 8.0mm, and the cf during the ablation was 5g.The length of hospitalization was extended.Timing was 4 hours after the start of the procedure, at the time of at ablation.The ablation was discontinued and the pacemaker was inserted.Description of health hazard is heart block.Methods of cf monitoring was dashboard and vector.Coloring setting of visitag was tag index.Physician's comment on the relationship between the event and the product was that the procedure was too much for them and should have stopped much earlier.There were no abnormalities before using the product.Additional information was received on 11-jul-2023.It was discovered during use of biosense webster products.The ablation was discontinued and a pacemaker was implanted.Additional information was received on 14-jul-2023.The ablation was discontinued and the temporally pacemaker was inserted.Visitag parameters for stability: range:3.0mm, time:3s, fot:25% 3, tag size:2.No additional filter was used.Progress: after the patient left the catheter room, the atrioventricular block did not improve, so an implantable pacemaker procedure was performed on the next day (b)(6)2023.The hospitalization was scheduled to be extended for 6 days.On (b)(6) 2023, the implantable pacemaker will be checked and if no problems were confirmed, the patient was scheduled to be discharged on the same day.During the extended hospitalization period, there was no occurrence of the treated arrhythmia confirmed.No problems with the products, which were available to use as usual.Because the procedure time got longer and the mapping was difficult, they were lack of awareness for the ablation of anatomical high risk areas.There were no abnormalities observed during use of the product.No special note on history/treatment/other current diseases being treated.Physician¿s opinion on the cause of this adverse event was that it was procedure related.No problems with the products, which were available to use as usual.Because the procedure time got longer and the mapping was difficult, there was lack of awareness for the ablation of anatomical high risk areas.Outcome of the adverse event was improved.On (b)(6) 2023, the implantable pacemaker will be checked and if no problems were confirmed, the patient was scheduled to be discharged on the same day.During the extended hospitalization period, there was no occurrence of the treated arrhythmia confirmed.The hospitalization was scheduled to be extended for 6 days.

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).

Manufacturer Narrative

The investigation was completed on 04-aug-2023.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31049268l number, and no internal action 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 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: 17454820
• MDR Text Key: 320373118
• Report Number: 2029046-2023-01696
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• 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: 31049268L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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
• Treatment: UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female