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

Model Number D134701

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received photographs of the complaint device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a cerebrovascular accident.It was reported that there was spike in impedance, char on catheter.Patient experienced apoplexy (stroke).Additional information- the adverse event occurred on (b)(6) 2022.It was discovered post use of bw products.Outcome of the adverse event was fully recovered (no residual effects).The patient required extended hospitalization.Smart ablate, serial #: (b)(6) was used.Thermocool® smarttouch® sf catheter was used.All force visualization features were used.No additional filter used with the visitag.Tag index was used.The generators serial # was: (b)(6).The pumps serial # was: (b)(6).The longest ablation was 51 sec.Irrigation rate was not used outside of those prescribed.Pictures attached.Additional information-intervention provided was ablation of atrial fibrillation and atypical atrial flutter and control of previously cavotricuspid ishmus (cti) block.Patient required extended hospitalization because of the adverse event due to ct cerebrum verified right occipital infarct as he was admitted for 1 extra day.Relevant tests/laboratory data- hemoblobin 9.4 mmol/l, creatinine 120 ¿mol/l, platelets 183 10e9/l.No other medical history.The char was located to the tip and to the distal part of the catheter.There was impedance spike and therefore the catheter was withdrawn from the patient and inspected where the char formation was observed and the catheter was replaced with a new one.Impedance spike was observed.Patient was anticoagulated.Prior the procedure the patient was treated with apixaban 5 mg *2 for more than 6 months with no pause.Immediately after transseptal puncture the patient was treated with iv heparin and act measured every 15-30 min during the procedure and if below 300, additional heparin was administrated.The patient developed neurological symptoms at the end of the procedure, visus symptoms.Heparinized normal saline only was used as the irrigation fluid.The impedance cut-off value was exceeded and the ablation was stop by the system.High impedance is not mdr-reportable.Char is not mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 18-june-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 24-may-2023, the photo analysis was completed.It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a cerebrovascular accident.It was reported that there was spike in impedance, char on catheter.Patient experienced apoplexy (stroke).Additional information- the adverse event occurred on (b)(6) 2022.It was discovered post use of bw products.Outcome of the adverse event was fully recovered (no residual effects).The patient required extended hospitalization.Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, a spikes on the impedance value were observed on the carto 3 screen, the impedance issue was confirmed based on the photo provided.Also, the photos does not provided sufficient information related to the char reported by the customer, and therefore no results can be obtained from it.The char issue could not be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30960277l and no internal action related to the complaint was found during the review.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.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 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: 16752966
• MDR Text Key: 313446374
• Report Number: 2029046-2023-00831
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

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: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30960277L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 05/24/2023; 07/17/2023
• Supplement Dates FDA Received: 06/08/2023; 07/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2023
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR; SMARTABLATE PUMP
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 85 KG