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

Catalog Number D134805

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2023.The device evaluation was completed on (b)(6) 2023.Visual analysis of the returned sample revealed reddish material and a hole in the pebax.The magnetic feature was tested and no errors were observed.The reddish material found inside the pebax area may contribute to the visualization issue reported.A manufacturing record evaluation was performed and no internal action was found during the review.The issue reported by the customer was confirmed.The instructions for use contain (ifu) the following recommendations: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) 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 as soon as ablation was started, the catheter (lot #: 31047172l) dropped off the screen and outside the geometry during ablation.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.It was noted that there was an inside catheter in the clearance section where the coils are.The case continued.The initial issue reported was assessed as non mdr reportable.If the device was not visualized by the carto system, the user will have to replace the catheter in order to complete the case.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023 there was reddish material and a hole in the pebax observed.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 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: 17556592
• MDR Text Key: 321551166
• Report Number: 2029046-2023-01787
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• 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: 31047172L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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; UNKNOWN BRAND CABLE