MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problem Obstruction of Flow (2423)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an intermittent or low irrigation issue occurred.It was reported that during the procedure, there was an intermittent or low irrigation on the device but not complete occlusion.No error reported.¿after passing water outside the body¿, it was determined that the blockage was at the end of the catheter.After replacing the catheter to continue the surgery, the problem disappeared.A second device was used to complete the operation.There was no adverse event reported on patient.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an intermittent or low irrigation issue occurred.It was reported that during the procedure, there was an intermittent or low irrigation on the device but not complete occlusion.No error reported.¿after passing water outside the body¿, it was determined that the blockage was at the end of the catheter.After replacing the catheter to continue the surgery, the problem disappeared.A second device was used to complete the operation.There was no adverse event reported on patient.Device investigation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, patency and irrigation test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A patency and irrigation test were performed, and the device was flushing correctly.No obstructed holes were observed and no irrigation issues were observed.A manufacturing record evaluation (mre) was performed for the finished device 31124319m number, and no internal action related to the complaint was found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.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.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 18311648
• MDR Text Key: 330943072
• Report Number: 2029046-2023-02916
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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 Catalogue Number: D133604IL
• Device Lot Number: 31124319M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE SYSTEM-PUMP CHINA.