MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D133602
Medical Device Problem Codes	Insufficient Cooling (1130); Obstruction of Flow (2423); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch and an irrigation issue occurred.When ablaiting the temperature raised very fast and the power wasn¿t raising.Only one of the porus of the st was irrigating.The catheter was changed and procedure was successfully completed.There was a 5 minute delay in the procedure.There were no patient consequences.
Additional Manufacturer Narrative
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.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On 17-feb-2025, 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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch and an irrigation issue occurred.When ablaiting the temperature raised very fast and the power wasn¿t raising.Only one of the porus of the st was irrigating.The catheter was changed and procedure was successfully completed.There was a 5 minute delay in the procedure.There were no patient consequences.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection, irrigation, temperature and impedance test of the returned device were performed following j&j procedures.Visual analysis revealed a damage on one electrode and reddish material inside the pebax.The electrode was observed lifted and sharp, but no internal components were exposed.No damage was identified on the pebax's surface.Then, the temperature and impedance test were performed and the device was found to be working correctly.No temperature or impedance issues were observed.An ablation cycle was perform an no power issue was identified during the analysis.Finally, and irrigation test was performed, and the device was irrigating correctly.No obstructed holes or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material inside the pebax could related to the temperature and power issue reported by the customer; therefore, the complaint was confirmed.The potential cause of the electrode damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.In the other hand, the irrigation 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 instruction for use (ifu) contains the following warnings and precautions: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostatic valve of the sheath.After insertion, slide the insertion tube back toward the handle.Do not scrub or twist the tip electrode because damage to the tip electrode bond may occur and loosen the tip electrode, or damage to the contact force sensor and affect measurement accuracy.If during ablation, temperature does not rise, discontinue delivery of energy and check setup.Apparent low power output, high impedance reading, or failure of the equipment to function correctly at normal settings may indicate faulty application of the indifferent electrode(s) or failure of an electrical lead.Do not increase power before checking for obvious defects or misapplication of the indifferent electrode.In relation to the irrigation issues, the instructions for use (ifu) contain the following warnings and precautions: a compatible irrigation pump is recommended to ensure proper irrigation flow rate.Before use, verify that the irrigation ports are patent by infusing heparinized normal saline through the catheter and the irrigation tubing.Purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Explanation of codes: investigation findings: operational problem identified (c13) and stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: tip (g04129) and electrode (g0201501) were selected as related to the reddish material inside the pebax and lifted electrode identified by bwi pal.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported irrigation issue.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH
• Common Device Name: 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: 21375369
• Report Number: 2029046-2025-00416
• Device Sequence Number: 8459103
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)270809(10)31400094M
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: D133602
• Device Lot Number: 31400094M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/17/2025; 02/27/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/18/2025; 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown