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

Catalog Number	D134801
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 10-apr-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.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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch sf which had a foreign material in the connector section which was introduced into the sterile field.It was initially reported by the customer that at the time of opening the catheter, there was a foreign object in the cable connection area, preventing the catheter from being connected to the cable.The issue was resolved by replacing the smart touch sf catheter and the cable.The procedure was completed without patient's consequence as the device was not used on the patient.The customer's reported foreign material in the connection port was not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 24-apr-2025, additional information was received indicating the device was actually introduced into the sterile field and was connected to a catheter at the feet side of the patient who was covered with a drape.Based on this new information, the event was reassessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool smarttouch sf which had a foreign material in the connector section which was introduced into the sterile field.It was initially reported by the customer that at the time of opening the catheter, there was a foreign object in the cable connection area, preventing the catheter from being connected to the cable.The issue was resolved by replacing the smart touch sf catheter and the cable.The procedure was completed without patient's consequence as the device was not used on the patient.The device was actually introduced into the sterile field and was connected to a catheter at the feet side of the patient who was covered with a drape.Device evaluation details: the device was returned to johnson & johnson medtech for evaluation.Visual inspection and deflection test of the returned device were performed following johnson & johnson medtech procedures.Visual analysis revealed foreign material in the connector area.The particle found in the catheter connector was made of polyurethane (pu), a material used during the assembly process.The exact root cause of the reported issue could not be determined.An awareness session was performed with manufacturing to avoid this issue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material issue reported by the customer was confirmed.The instruction for use contain the following recommendations: using aseptic technique, remove the catheter from the package and place it in a sterile work area.Inspect the catheter carefully for electrode integrity and overall condition; the sterile packaging and catheter should be inspected prior to use.Do not use the catheter if the packaging or catheter appears damaged.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 SF
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22054427
• Report Number: 2029046-2025-01640
• Device Sequence Number: 15219396
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: (01)10846835010145(17)251107(10)30916774L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• 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

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 Expiration Date: 11/07/2025
• Device Catalogue Number: D134801
• Device Lot Number: 30916774L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CABLE.
• Patient Sex: Unknown