MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number D134825IL

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

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a reddish material and a hole in the pebax.Initially, it was reported that during the operation, there was a problem with the force of the catheter.A second device was used to complete the operation.There was no adverse event reported on patient.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 21-feb-2024, there was a reddish material and a hole in the pebax.This was assessed as mdr reportable with an awareness date of 21-feb-2024.

Manufacturer Narrative

The thermocool® smart touch® sf bi-directional navigation catheter 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 and a hole in the pebax.This could be related to the handling and/or manipulation during the procedure.However, this cannot be conclusively determined.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.The blood found inside the pebax area may have contributed to the force and magnetic issue.A manufacturing record evaluation was performed for the finished 30991634l device number, and no internal actions related to the reported complaint condition were identified.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.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch® sf bi-directional navigation catheter approved under pma # p030031/s053 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: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 18925703
• MDR Text Key: 337956266
• Report Number: 2029046-2024-00891
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: D134825IL
• Device Lot Number: 30991634L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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