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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
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.D4: udi: the manufacturing and expiration dates are currently unavailable.Therefore, the full udi is currently not available.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a thermocool smarttouch and some irrigation holes were occluded.It was reported the thermocool smarttouch catheter seems slightly obstructed and does not allow to ablate because when ablating with smartablate the temperature cut-off was quickly reached.Also when flushing the catheter outside of the patient we don¿t see water coming through every hole at the tip.Another catheter from a different lot had to be used.There were no patient consequences.On 3-jul-2024, additional information was received indicating the issue occurred while the device was being used on the patient.They tried to flush the irrigation tubing set without the catheter and there was no issue.With the catheter during the flush the water was not going through each hole homogeneously.There was no error on the smartablate pump, only on the smartablate generator.As such, the event was reassessed as an mdr reportable malfunction based on the new information received.
Additional Manufacturer Narrative
On 6-aug-2024, 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 the thermocool smarttouch catheter seems slightly obstructed and does not allow to ablate because when ablating with smartablate the temperature cut-off was quickly reached.Also when flushing the catheter outside of the patient we don¿t see water coming through every hole at the tip.Another catheter from a different lot had to be used.There were no patient consequences.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, temperature and impedance, and pump and pressure gauge test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.A pump and pressure gauge test were performed, and the device was irrigated correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The high temperature and irrigation issues 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 recommendations: when rf current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned.Make sure the irrigation holes are not plugged prior to re-insertion.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Correction: it was noticed the incorrect date received by manufacturer was reported in field g3 of the 3500a initial medwatch report.The incorrect date reported was 3-jul-2024.Please consider 1-jul-2024 to be the correct date.Note: the full udi has now been provided under field d4.Primary udi number.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 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: 19833738
• Report Number: 2029046-2024-02503
• Device Sequence Number: 7504955
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: (01)10846835009002(17)270519(10)31325153M
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,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: 31325153M
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 08/23/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/07/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK_SMARTABLATE GENERATOR; UNK_SMARTABLATE PUMP
• Patient Sex: Unknown