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

Model Number D134805

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial tachycardia (at) right ablation procedure with two thermocool® smart touch® sf bi-directional navigation catheters and an issue with bad/no ecg on all channels occurred.It was reported that there was noise ablation distal and proximal and all 12-leads on the mapping, recording, and anesthesia monitor.They switched the ecg trunk cable and swapped the leads cables as well, but the issue did not resolve.The cable was replaced without resolution.The catheter was replaced, however, the issue continued.Catheter and cable.Grounding pad on the patient.The generator was replaced, the pump was replaced, and the issue did not resolve.The generator to pump cable was replaced but the noise issue was still there.The spu was not in use, so they disconnected the spu power cord, but the issue was still there.Restarted the piu and magnet but that made no difference.Brought in a new piu magnet and other part of the system from another room and the issue was still there.¿when in with a low wattage signal¿ and the anesthesia team noticed that the noise in and out matches the patient's respirations.While looking at fluoro and noticed when the patient defibrillator leads were closed to the catheter's ablation signals and the leaked signal was entering the patient's body and causing the noise issue.The noise was on all body surface (bs) and ablation intracardiac (ic) on both carto and recording system.Cs ic (also through our piu) had no noise on either carto or recording system.During radiofrequency (rf), the physician had no intact bs ecg to monitor patient¿s heart rate (noise washed out all bs ecgs).With cessation of rf, all bs ecgs returned to normal.The case continued and ended successfully.No adverse patient consequence was reported.The bad/no ecg on all channels is mdr reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4), has two reports: (1) mfr # (b)(4) for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-01212 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 12-jun-2023.The device evaluation was completed on 05-jul-2023.It was reported that a patient underwent an atrial tachycardia (at) right ablation procedure with two thermocool® smart touch® sf bi-directional navigation catheters and an issue with bad/no ecg on all channels occurred.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.An electrical test was performed, and no electrical issues were found.During product analysis, the lot number was verified to be 31025440l, based on the electronically erasable programmable read only memory (eeprom) file.Therefore, the d4.Lot, d4.Expiration date and h4.Device manufacture date have been updated.A manufacturing record evaluation was performed for the finished device number lot 31025440l and no internal actions related to the complaint were found during the review.The electrical issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number pc-001351334 has two reports: (1) mfr # 2029046-2023-01210 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-01212 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17056464
• MDR Text Key: 316864031
• Report Number: 2029046-2023-01210
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31025440L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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: THMCL SMTCH SF BID, TC, D-F.; UNK BRAND CABLE.; UNK BRAND CABLE.; UNK BRAND CABLE.; UNK GENERATOR.; UNK PUMP.