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

Model Number D134805

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

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.There was something like char attached circumferentially on the smart touch sf catheter.It was reported that after the procedure, something like a trace of char was attached circumferentially when the smart touch sf catheter was removed from the sheath.The reporter states that the char might have been shaved with the sheath and blown into the left atrium (la).There was no abnormality in contact force (cf) or impedance, and they thought it was an unavoidable event, so it did not become a major problem, but follow-up observation is required.There were no abnormalities before the use of the product.Additionally it was reported that the decanav catheter had a magnetic sensor error.This occurred when the catheter was connected.After replacing the cable, and the issue was resolved by changing the catheter to another one.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 28-dec-2021, bwi received additional information regarding the event.This adverse was event discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event: procedure.No effect to the patient was confirmed after the char issue and no intervention was reported.Generator information: smartablate.The thrombus was located at the tip of electrode.The system did not present any error messages.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 3-feb-2022, the product investigation was completed as the complaint device was not returned.Additionally, per internal review, the event assessment has been changed.It had been determined that the thrombus at the catheter tip was simply a thrombus, and that the patient had not experienced thrombosis/blood-clotting.Due to these findings, section b and h of this form have been updated.The following changes have been made: - the a2 checkmarks have been updated."serious injury", "life threatening", and "required intervention" no longer apply."product problem" has been selected.- the h1 type of reportable event section was updated from "serious injury" to "malfunction".- the h6 health effect - clinical code is no longer "thrombosis/thrombus" (e0514) and is replaced by "no clinical signs, symptoms or conditions" (e2403).- the h6 medical device problem code has been updated to "device contamination with body fluid" (a180103).Device investigation details: 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 30612860l number, and no internal actions 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13086772
• MDR Text Key: 282770742
• Report Number: 2029046-2021-02251
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 12/28/2021; 02/03/2022
• Supplement Dates FDA Received: 01/18/2022; 02/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2021
• 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: DECANAV CATHETER; DECANAV CATHETER; DECANAV CATHETER; SMARTABLATE GENERATOR; SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male