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

Catalog Number D133605IL

Device Problems Failure to Transmit Record (1521); Failure to Sense (1559)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation was completed on 12-dec-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, alert 106 "force catheter sensor error" and error 101 "map: catheter eeprom error" were observed on carto3 screen.The customer complaint was confirmed based on the picture received.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The magnetic and force features were tested and the device was recognized on the system; however, error 105 was displayed on the screen due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use contain (ifu) the following recommendations: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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.Explanation of codes: -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.-investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿101¿ error and ¿106¿ error.In addition, the biosense webster inc.Analysis finding of the ¿reddish material and a hole in the surface of the pebax.¿ -investigation findings: open circuit (c0205) / investigation conclusions cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported ¿101¿ error and ¿106¿ error.In addition, the biosense webster inc.Analysis finding of the ¿open circuit in the tip area¿.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a pvc procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax.Initially it was reported that when the catheter was inserted into the carto 3 machine, the system immediately showed a 101 and 106 error.A second device was used to complete the procedure.There was no adverse event reported on the patient.Catheter was not used in patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 12-dec-2023 there was reddish material and a hole in the surface of the pebax.This event was originally considered non-reportable, however, bwi became aware of a hole on the surface of the pebax on 12-dec-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

Additional information was received on 11-jan-2024, clarifying that the patient¿s date of birth which was processed the same as the event date of 13-sep-2023 in the 3500a initial was captured in error.Therefore, removed 13-sept-2023 from the a2.Date of birth field.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: 18466933
• MDR Text Key: 332904909
• Report Number: 2029046-2024-00100
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133605IL
• Device Lot Number: 31070978M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2023
• 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_CARTO 3.