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

Catalog Number D132705

Device Problems Communication or Transmission Problem (2896); Electrical Shorting (2926); Temperature Problem (3022)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 a non- ischemic ventricular tachycardia (isvt - right) (right ventricular outflow tract (rvot) ventricular tachycardia) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.Suddenly, during mapping, electrocardiogram (ecg) disappeared on both systems (conventional and carto).All the ecg signals disappeared.They noticed an error, leakage current has been detected, and noticed no temperature on radiofrequency (rf) ablator.The system was switched off and restarted and the issue persisted.All connection from the piu was restarted and the issue did not resolve.The cable was replaced, and the same issue occurred.They changed to a new smart touch catheter and completed the procedure.No adverse patient consequence was reported.

Manufacturer Narrative

It was reported that a patient underwent a non- ischemic ventricular tachycardia (isvt - right) (right ventricular outflow tract (rvot) ventricular tachycardia) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.Suddenly, during mapping, electrocardiogram (ecg) disappeared on both systems (conventional and carto).All the ecg signals disappeared.They noticed an error, leakage current has been detected, and noticed no temperature on radiofrequency (rf) ablator.The system was switched off and restarted and the issue persisted.All connection from the piu was restarted and the issue did not resolve.The cable was replaced, and the same issue occurred.They changed to a new smart touch catheter and completed the procedure.No adverse patient consequence was reported.Device evaluation details: on 28-nov-2023, the device was returned to biosense webster (bwi) for evaluation.Visual inspection, magnetic sensor functionality, electrical, temperature, and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed a greenish-white material presumably corrosion in the base of the connector pins.The device was connected to the carto 3 system, and it was visualized and recognized correctly.No current leakage error was observed.Electrical, temperature, and impedance tests were performed, and the device was found working correctly.No temperature, impedance, or electrical issues were observed.Since corrosion was observed.A flow test was performed for 30 minutes, and no leakage was detected.In addition, the device handle was dissected, and no corrosion was observed in the internal components.A manufacturing record evaluation (mre) was performed for the finished device number lot 31087931m 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.Since corrosion was observed in the connector pins, this failure could be related to the electrical and current leakage issues reported by the customer; therefore, the customer complaint was confirmed.It should be noted that product failure is multifactorial.The temperature issue could not be confirmed during the product investigation.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¿ BI-DIRECTIONAL NAVIGATION 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: 18171477
• MDR Text Key: 328638860
• Report Number: 2029046-2023-02704
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Device Lot Number: 31087931M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BRAND CABLE.; UNK BRAND CABLE.; UNK_CARTO 3.; UNK_SMARTABLATE GENERATOR.
• Patient Sex: Male