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

Model Number D134805

Device Problems Complete Blockage (1094); Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

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 an unknown patient underwent a persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident.After the procedure the patient had symptoms of a stroke upon awakening.The patient was under general anesthesia.It was also reported that there was high impedance and temperature during first rf applications.When the physician checked the tip of the ablation catheter, we observed char.The catheter was changed because all irrigation holes were clogged.The impedance cut-off was exceeded and the system stopped the ablation.The system did not continue to ablate above impedance cut-off value.Generator parameters: at the beginning of the procedure, for the 5 first points before the char was discovered, incorrect generator settings were selected: temperature cut-off 95°c and impedance cut-off 250 ohm.It is unknown if the system presented any error messages or if the physician/user see any product problem.The patient was anticoagulated after the trans septal punction.The physician considers that the char is excessive.The duration of ablation used was not greater than 60 seconds.There was average contact force greater than 40 grams for a few seconds.Carto visitag module was used: respiration setting, stability range, stability time, force over time, & tag size.3s, 3g, 3mm, 25%.Char is not mdr-reportable.High temperature is not mdr-reportable.High impedance is not mdr-reportable.Clogged irrigation is not mdr-reportable.However, the event is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

On 8-feb-2022, the bwi product analysis lab received the 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.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(b)(6)-2022, the product investigation was completed.It was reported that an unknown patient underwent a persistent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident.After the procedure the patient had symptoms of a stroke upon awakening.The patient was under general anesthesia.Device evaluation details: visual inspection revealed no damage or anomalies on the device, no char was observed; however, char was observed at the decontamination site.The char residues could have been lost during the decontamination process.Per the event, several tests were performed.The magnetic, temperature, and screening features were tested.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30661613l number, and no internal action related to the complaint was found during the review.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the catheter that could not be replicated during the analysis.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13202705
• MDR Text Key: 284209775
• Report Number: 2029046-2022-00060
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30661613L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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; UNSPECIFIED GENERATOR; VISITAG MODULE
• Patient Outcome(s): Required Intervention; Life Threatening