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

Catalog Number D134701

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

E 1.Initial reporter address line (b)(6).The device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material and a hole in the pebax.The root cause of the hole in the pebax could be related to the handling of the device during the procedure.However, this cannot be conclusively determined.The reddish material inside the pebax could be related to the force issue reported by the customer.A manufacturing record evaluation was performed, and no internal action was found during the review.The customer complaint was confirmed.It should be noted that product failure is multifactorial.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.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 for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially, it was reported that the contact pressure of the catheter was in the normal range and increased very quickly and extremely several times under ablation, although the catheter was not moved.When the catheter was removed from the patient, it was noticed that blood had collected in the catheter tip.The catheter could then no longer be detected by the system.The error message was displayed that it was outside the mapping range.A new catheter was used, after which, the problem immediately disappeared.No adverse patient consequence was reported.Additional information was received.It was reported that there were no error messages, but the contact pressure increased very quickly and extremely under ablation, although the catheter was not moved.When the ablation stopped, the contact pressure went back to the normal range there were no issues related to temperature and flow on the catheter.Normal saline was used as the irrigation fluid.The force issue and the foreign material (blood) were 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 26-jan-2024, there was reddish material and a hole in the pebax.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 26-jan-2024.

• 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: 18744684
• MDR Text Key: 335847184
• Report Number: 2029046-2024-00555
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

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 Catalogue Number: D134701
• Device Lot Number: 31049185LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2023
• 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: NGEN PUMP, EU CONFIGURATION; UNK_CARTO 3; UNK_NGEN RF GENERATOR