MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133605IL

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926)

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

Event Date 03/04/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein there was signal loss on all channels leaving no signal available to monitor the patient¿s heart rhythm.It was initially reported that a current leakage-device disruption error occurred.It was reported that during operation, leakage current was detected on patient interface unit (piu) rl input.A second catheter was used to complete the operation.There was no adverse event reported on patient.On 23-mar-2022, biosense webster inc received additional about the event indicating the "current leakage error" was displayed due to a signal noise / signal loss issue.The signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto® and recording system.No ecg/ekg signal were available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.The customer¿s initial report of current leakage-device disruption error is not considered to be an mdr reportable malfunction since the issue is highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.This event was originally considered non-reportable, however, bwi became aware of a reportable product malfunction based on additional information received on 23-mar-2022 and reassessed it as mdr reportable.

Manufacturer Narrative

The product has not returned for analysis, however, a picture(s) were provided by the customer.Evaluation is still in progress.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.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under p030031/s053.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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein there was signal loss on all channels leaving no signal available to monitor the patient¿s heart rhythm.It was initially reported that a current leakage-device disruption error occurred.It was reported that during operation, leakage current was detected on patient interface unit (piu) rl input.A second catheter was used to complete the operation.There was no adverse event reported on patient.(error code:7) on 23-mar-2022, biosense webster inc received additional about the event indicating the "current leakage error" was displayed due to a signal noise / signal loss issue.The signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto® and recording system.No ecg/ekg signal were available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.Device investigation details: according to pictures provided by customer, error 7, current leakage was observed on carto 3 screen.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 the device is received in the future, the product investigation will be performed and updated accordingly, and additional actions will be taken as necessary.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the video analysis results.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 (b)(6) 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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein there was signal loss on all channels leaving no signal available to monitor the patient¿s heart rhythm.It was initially reported that a current leakage-device disruption error occurred.It was reported that during operation, leakage current was detected on patient interface unit (piu) rl input.A second catheter was used to complete the operation.There was no adverse event reported on patient.(error code:7) on (b)(6) 2022, biosense webster inc received additional about the event indicating the "current leakage error" was displayed due to a signal noise / signal loss issue.The signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto® and recording system.No ecg/ekg signal were available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, magnetic sensor functionality, and eelectrical tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed that no damage was observed on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues were observed.An electrical test was performed, and an open circuit was found on the shaft area.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer reported current leakage.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the signal loss issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14106891
• MDR Text Key: 290152988
• Report Number: 2029046-2022-00800
• 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,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Catalogue Number: D133605IL
• Device Lot Number: 30621930M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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 SMARTTOUCH,TC,F,C3,OBL