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

Catalog Number D134805

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially, it was reported that during the procedure, it was necessary to replace the smart touch ablation catheter due to contact sensor problems.The issue was resolved when the catheter was replaced and the procedure was successful.No adverse patient consequence was reported.The force issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 23-jan-2024, a yellowish-colored condition, as well as a hole in the pebax were noted.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 23-jan-2024.

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).The product was returned to biosense webster (bwi) for evaluation.Bwi conducted a visual inspection and screening test of the returned device following bwi procedures.Visual inspection uncovered a yellowish-colored condition and a hole in the pebax.The peek housing was also noted to be twisted and bent, with no exposed internal components.The root cause of the damage may be linked to improper handling.While the yellowish- condition could potentially be associated with device usage, this conclusion cannot be definitively determined.The device was connected to the carto 3 system and was recognized correctly; however, errors 105 and 106 appeared on the system.Further examination determined failures of two open circuits in the shaft area and one open circuit in the tip area.The pebax condition could also be linked to the errors displayed in the system during the product test.The issue reported by the customer was confirmed.Product failure is multifactorial; the instructions for use contain the following recommendations stated in the carto 3 system manual: the force and magnetic sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.A manufacturing record evaluation was performed for the finished device number 31047036l, and no internal action was found during the review.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: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the peek housing issue.Investigation findings: open circuit (c0205)/ investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to errors 105 and 106 that were displayed.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the hole in the pebax.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: cable, electrical (g02004) were selected as related to the open circuits in the shaft and tip areas.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).

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 18704926
• MDR Text Key: 336509122
• Report Number: 2029046-2024-00497
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31047036L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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: THMCL SMTCH SF BID, TC, D-F
• Patient Sex: Male