MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D134722IL

Device Problem Signal Artifact/Noise (1036)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and all ecg signals were lost during procedure.During the operation, the signal interference (noise) was observed on ic, bs, or all ecg (bs + ic) channels.A second catheter was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported noise issue was not considered to be mdr reportable since the risk to the patient is low on 30-dec-2021, additional information was received indicating the signal interference (noise) was observed on all ecg (bs+ic) channels on both the carto® and recording system.The physician did not have any intact ecg signal available to monitor patient heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.Based on this new information received on 30-dec-2021 , the event was assessed as an mdr reportable malfunction since the lack of monitoring of cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.

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 ref.# (b)(4).

Manufacturer Narrative

On 13-jan-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.#(b)(4).

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and all ecg signals were lost during procedure.The signal interference (noise) was observed on all ecg (bs+ic) channels on both the carto® and recording system.The physician did not have any intact ecg signal available to monitor patient heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.There was no adverse event reported on patient.Device evaluation details: the complaint product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and electrical evaluation of the returned device.Visual analysis of the returned sample revealed no damages on the thermocool® smart touch® sf uni-directional navigation catheter.An electrical test was performed following bwi procedures.The device passed the electrical values within specification.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 batch number, and no internal actions were identified.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 analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: on 2-mar-2022, it was noticed the following information was inadvertently omitted from the 3500a initial mdr under section h10.Additional manufacturer narrative: "the customer provided a photo of the reported issue to aid in the investigation.According to pictures provided by customer, noise was observed on carto 3 screen.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.".

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 13233435
• MDR Text Key: 287584386
• Report Number: 2029046-2022-00080
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/02/2022

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: 09/13/2022
• Device Catalogue Number: D134722IL
• Device Lot Number: 30642553L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/13/2022; 02/13/2022
• Supplement Dates FDA Received: 01/18/2022; 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF UNID, TC, F, IL.