MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D7BTCFL252RT

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a celsius¿ electrophysiology catheter and the biosense webster inc.Product analysis lab observed electrode #1 and electrode #4 inverted.Initially it was reported that the celsius¿ electrophysiology catheter was defective.Upon the connection to the smartablate generator, impedance values were off, exceeding a value of 250.Ablation was impossible due to impedance cut off of 250.When withdrawn from the patient, the customer noticed a charring like stain on electrodes 3 and 4.Due to the impedance issue and visible error on electrodes, the catheter was replaced with a new one and the procedure performed successfully with new catheter.There was no patient consequence reported.The surgery was not delayed due to the reported event.The procedure was completed successfully.Additional information was received.The system presented an error message.Impedance readings were unphysiological and generator prevented ablation.The generator was set to temperature control mode with temperature cut off at 95.Temperature and power were not provided.Impedance exceeded 250.The physician considered that the char was excessive.The physician did not consider the amount of char observed caused a potential risk to this patient.The high impedance cut off exceeded with ablation stopped issue was assessed as not mdr reportable.Since the user-defined cut-off was exceeded and ablation was stopped, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The char issue was assessed as not mdr reportable.Char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.The biosense webster, inc.Product analysis lab received the device for evaluation and observed that the electrode #1 and electrode #4 were inverted.This issue was assessed as mdr reportable.The awareness date for this reportable lab finding was 02-sep-2022.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 03-aug-2022.The 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a celsius¿ electrophysiology catheter and the biosense webster inc.Product analysis lab observed electrode #1 and electrode #4 inverted.Initially it was reported that the celsius¿ electrophysiology catheter was defective.Upon the connection to the smartablate generator, impedance values were off, exceeding a value of 250.Ablation was impossible due to impedance cut off of 250.When withdrawn from the patient, the customer noticed a charring like stain on electrodes 3 and 4.Due to the impedance issue and visible error on electrodes, the catheter was replaced with a new one and the procedure performed successfully with new catheter.There was no patient consequence reported.The surgery was not delayed due to the reported event.The procedure was completed successfully.Additional information was received.The system presented an error message.Impedance readings were unphysiological and generator prevented ablation.The generator was set to temperature control mode with temperature cut off at 95.Temperature and power were not provided.Impedance exceeded 250.The physician considered that the char was excessive.The physician did not consider the amount of char observed caused a potential risk to this patient.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, temperature and impedance test, and electrical test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the device.The temperature and impedance test was performed and it was noticed that the ablation was performed with electrode #4.An electrical test was performed to verify the electrodes and it was found that electrode #1 and electrode #4 are inverted.For this condition, further activities were performed including a meeting with the manufacturing team in order to find the root cause.During the analysis and investigation of the compliant device with the reported condition of ¿high impedance and char¿, it was inspected, and it was determined that the issue is manufacturing related due to a wrong connection between electrode 4 and electrode 1 (dome).It should be noted that product failure is multifactorial.Based on the available information, a product issue was identified during the investigation of the sample received.This product issue will be addressed through bwi¿s quality system.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Please note that during the investigation process it was discovered that the finding of the electrode #1 and electrode #4 being inverted may lead to an adverse event which is why this finding was assessed as a reportable malfunction.Explanation of codes: investigation findings: appropriate term/code not available (c22)/ investigation conclusions: cause traced to manufacturing (d03) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Product analysis lab finding of the ¿electrode #1 and electrode #4 inverted" issue.Investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿high impedance cut-off exceeded (ablation stopped)¿ issue.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿char¿ issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on 02-mar-2023, the product investigation was reopened to clarify/correct the investigation coding which resulted in the following changes/corrections.Explanation of codes: -investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: electrical lead/wire (g02015) were selected as related to the biosense webster inc.Product analysis lab finding of the ¿electrode #1 and electrode #4 inverted" issue.-investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿high impedance cut-off exceeded (ablation stopped)¿ issue.-investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿char¿ issue.In addition, noted correction on 23-mar-2023 to the 3500a follow-up #1 as in error did not include the h6.Type of investigation codes.Therefore, processed.

• Brand Name: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15513548
• MDR Text Key: 301519628
• Report Number: 2029046-2022-02343
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835005257
• UDI-Public: 10846835005257
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950005/S2
• 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,Followup
• Report Date: 03/25/2023

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 Model Number: D7BTCFL252RT
• Device Catalogue Number: D7BTCFL252RT
• Device Lot Number: 30727696M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/22/2022; 03/02/2023
• Supplement Dates FDA Received: 10/20/2022; 03/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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: SMARTABLATE GENERATOR KIT-WW; UNKNOWN BRAND CATHETER