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

Catalog Number	D134802
Medical Device Problem Codes	Obstruction of Flow (2423); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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® smart touch® sf bi-directional navigation catheter and the catheter would not irrigate and there was a plastic film on the tip.It was reported by the bwi representative that during a procedure the catheter would not irrigate and was fully occluded.The caller stated that when they pulled out the catheter, the physician said it looked as though there was a plastic film on the tip of the catheter.To troubleshoot the physician tried to irrigate the catheter without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.There was no patient consequence.Additional information was later received indicating the catheter was flushed multiple times with the catheter in the patient, but with the stopcock closed to the patient.Irrigation flow from the pump was normal when the stopcock was off to the patient.After numerous flushing rounds failed to reaolve the issue, the catheter was withdrawn from the body and the tip was visually inspected and found to be occluded.The foreign material had a cloudy white appearance and covered the entire tip of the catheter.The physician said it was difficult to remove from the catheter tip.The physician did not mention feeling any resistance when introducing the catheter into the sheath.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the catheter would not irrigate and there was a plastic film on the tip.It was reported by the bwi representative that during a procedure the catheter would not irrigate and was fully occluded.The caller stated that when they pulled out the catheter, the physician said it looked as though there was a plastic film on the tip of the catheter.To troubleshoot the physician tried to irrigate the catheter without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, patency, and pump pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no plastic film on the tip of the device.A pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.Additionally, a patency test was performed, and the device was flushing correctly, no obstructed holes were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The 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 recommendations: flush the catheter with heparinized saline prior to insertion into the body.As part of biosense webster¿s 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.# (b)(4).
Additional Manufacturer Narrative
On 4-mar-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).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• 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: 18694457
• Report Number: 2029046-2024-00482
• Device Sequence Number: 8332155
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: 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: D134802
• Device Lot Number: 31180272L
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: 03/04/2024; 03/08/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/07/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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: ABBOTT, SL-1, 8.5FR SHEATH; NGEN PUMP, US CONFIGURATION; UNK_CARTO 3
• Patient Sex: Unknown