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

Catalog Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Renal Impairment (4499)

Event Date 08/02/2023

Event Type  Injury  

Event Description

During a clinical trial, it was reported that patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the patient suffered cardiac tamponade and acute kidney failure requiring medication.On (b)(6) 2023, the patient experienced cardiac tamponade categorized as severe and serious.The relationship to study device was reported as not related and causal relationship to primary index study.The adverse event was expected/anticipated.The patient¿s outcome was reported as recovered/resolved.No information regarding intervention was provided.On (b)(6) 2023, the patient experienced acute renal failure categorized as mild severity and serious.In-patient or prolonged hospitalization was required.The relationship to study device was reported as not related and possibly related to the primary index study procedure.The adverse event was expected/anticipated.The patient¿s outcome was reported as recovered/resolved.Medication was given as medical intervention.

Manufacturer Narrative

Device investigation details: available information 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 31085422l number, and no internal actions related to the complaint was found during the review.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

On 28-sep-2023, additional information was received indicating the ¿agilis sheath¿ has been inactivated.Please consider this removed from the concomitant product section.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 4-oct-2023, it was noticed that incorrect information was reported in section b5.Event description of the 3500a initial medwatch report.I was reported that patient suffered cardiac tamponade requiring no medical intervention, however, it should have been reported that the patient intervention was ¿punctuation¿ pericardiocentesis.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 17-oct-2023, during an internal review of this file it was determined that it was incorrectly reported that the ¿agilis sheath¿ should no longer be considered a concomitant device.This was incorrect.Please consider a concomitant device which has been re-added to the concomitant product section.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 17670773
• MDR Text Key: 322509772
• Report Number: 2029046-2023-01975
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Device Lot Number: 31085422L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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: AGILIS SHEATH; AGILIS SHEATH; CARTO 3 SYSTEM; NGEN RF GENERATOR; PENTARAY NAV ECO 7FR, F, 2-6-2
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 120 KG