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 Cardiac Tamponade (2226)

Event Date 11/15/2022

Event Type  Injury  

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.The patient suffered cardiac tamponade requiring a pericardiocentesis.The procedure was completed with pvi and cti as usual.After removing the sheath postoperative and performing hemostasis, the pericardial effusion was confirmed by postoperative chest echography, so drainage was performed.As the procedure had been completed, after performing drainage, the patient returned to the room.The patient's state was improved.Cardiac tamponade atrial septal puncture was performed by rf needle.Ablation was performed before pericardial effusion was identified.Steam pop was not confirmed.Irrigation catheter¿s flow rate setting: < 35 w, 8 ml = 35 w, 15 ml.The physician's opinions on the relationship between the event and the product was that there was a lot of body movement due to pain during the procedure, so they might have hurt something during that.They do not think the event occurred during conducting ablation.There were no abnormalities observed prior to and during use of the product.Additional information was received.The adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The outcome of the adverse event was improved.Rf needle was used for the transseptal puncture performed.Ablation was performed prior to noting the cardiac tamponde.There was no evidence of steam pop.No error messages observed on biosense webster equipment during the procedure.

Manufacturer Narrative

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.A manufacturing record evaluation was performed for the finished device 30869386l 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.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

Additional information was received on 15-dec-2022.Force visualization features used were real time graph; dashboard; vector; visitag.Additional filter used with the visitag was fot.Color options used prospectively was tag index.Additional information was received on 23-dec-2022.Physician¿s opinion on the cause of this adverse event was the procedure.Relevant tests/laboratory data---no further information is available.Other relevant history---no further information is available.The issue was observed on biosense webster equipment during the procedure.Therefore, added the unk_carto 3 system under the d 10.Concomitant medical products and therapy dates.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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15974793
• MDR Text Key: 305414386
• Report Number: 2029046-2022-03099
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 30869386L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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: LASSO NAV 2515,22P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER; UNKNOWN BRAND RF NEEDLE; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 42 KG