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

Model Number D134805

Device Problem High Readings (2459)

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

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 16-feb-2023.The device evaluation was completed on 24-feb-2023.The thermocool® smart touch® sf bi-directional navigation catheter device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material in the pebax.The magnetic and force features were tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.Scanning electrode microscope analysis showed evidence of mechanical damage and a hole on the pebax surface.The blood found inside the pebax area may have contributed to the force issue.A manufacturing record evaluation was performed for the finished device 30928387l number, and no internal action was found during the review.The issue reported by the customer was confirmed.The instructions for use contain the following information that should be considered: 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.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.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.Biosense webster manufacturer's reference number: (b)(4) has two reports: (1) mfr#: 2029046-2023-00330 for product code: d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium) (2) mfr#: for product code: d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib)ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the biosense webster inc, (bwi) product analysis lab observed a reddish material in the pebax.Initially, it was reported that the carto 3 system displayed "hi" force for the stsf catheter, and there was a catheter interference alert displayed as well.The cable was replaced without resolution.The stsf catheter was replaced, and the issue resolved.The procedure continued.No adverse patient consequences were reported.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 24-feb-2023 that there was evidence of mechanical damage and a hole on the pebax surface.This finding was assessed as mdr reportable.The awareness date for this reportable lab finding is 24-feb-2023.

• 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: 16583698
• MDR Text Key: 312232926
• Report Number: 2029046-2023-00591
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30928387L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; 8.5F SHEATH WITH CURVE VIZ MDC; THMCL SMTCH SF BID, TC, D-F; UNK BRAND CABLE; UNK BRAND CABLE