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

Model Number D134805

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was no intact ecg signal available to monitor the patient¿s heart rhythm.Initially it was reported that the thermocool® smart touch® sf bi-directional navigation catheter noise in use was not bent properly.There was a problem on the catheter signal showing during the procedure.The cable was unplugged and plugged in again.It did not resolve the issue.Secondly the cable was replaced with a new one.Third the patient interface unit (piu) was not turned on and off.Finally, the catheter was replaced and the issue resolved.There was no patient consequence reported.The signal issue was assessed as not mdr reportable as the risk to the patient was low.Additional information was received on 10-nov-2021.The signal interference (noise) was observed on all ecg (bs + ic) channels.The signal interference (noise) was observed on carto® and recording system.The physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.Per the additional information stating that there was no intact ecg signal available to monitor the patient¿s heart rhythm, the signal issue has been reassessed to mdr reportable.The awareness date for this reportable issue is 10-nov-2021.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 01-dec-2021.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.(b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was no intact ecg signal available to monitor the patient¿s heart rhythm.The device evaluation was completed on 16-dec-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and electrical evaluation of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the smart touch bidirectional sf.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 30571458l number, and no internal actions related to the complaint were found during the review.No electrical issues related to the reported event were found.To minimize ecg noise, the following guidelines should be followed.Ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.The event described could not be confirmed as the device performed without any electrical issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory 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).

Manufacturer Narrative

Additional information was received on 14-dec-2021 providing the facility name.Therefore, populated ¿e1.Initial reporter facility name¿ field.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12945139
• MDR Text Key: 285545159
• Report Number: 2029046-2021-02123
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30571458L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 12/14/2021; 12/16/2021
• Supplement Dates FDA Received: 12/14/2021; 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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: UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM; UNK_CARTO 3