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

Model Number D134702

Device Problem High Readings (2459)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 02-may-2023.The product was returned to biosense webster (bwi) for evaluation 08-mar-2023.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned sample revealed a cut on pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue.A screening test was performed, and the device was recognized correctly; however, hi force error appeared.The force issue reported by the customer was confirmed.The evaluation determined that the cause of pebax damage failure cannot be established.However, the blood found inside the pebax area may have contributed to the high force error displayed on the carto 3 system.The instructions for use (ifu) contain the following recommendations: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.If the force problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device 30821222l number, and no internal action related to the complaint was found during the review.Biosense webster's quality process ensures all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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 cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the biosense webster inc, (bwi) product analysis lab observed a cut on the pebax with reddish-brown material inside and internal parts exposed.Initially, it was reported that force would go high during ablation.There was no patient consequence.The force issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found on 02-may-2023, a cut on pebax with reddish-brown material inside and internal parts exposed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 02-may-2023.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 17013225
• MDR Text Key: 316051342
• Report Number: 2029046-2023-01165
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030031
• 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
• Report Date: 05/26/2023

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 Expiration Date: 07/19/2023
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30821222L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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