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

Model Number D134805

Device Problems Display or Visual Feedback Problem (1184); Material Puncture/Hole (1504); Failure to Transmit Record (1521)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2021.Visual analysis of the returned catheter revealed reddish material inside and a hole on the pebax of the stsf catheter.Spi screening test was performed, in accordance with biosense webster, inc.(bwi) procedures.The returned sample was connected to the carto 3 system and error 106 was displayed on the screen.The catheter was dissected on the tip area, and loss of electrical continuity of the yellow paired wires to sensor was found.It was concluded that this is an internal failure of the sensor.A manufacturing record evaluation was performed for the finished device 30513948m number, and no internal action related to the complaint was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The evaluation determined that the cause of pebax damage failure cannot be established.The event described as visualization issue was unable to be duplicated during the product investigation; however, the reddish material inside the pebax area that was found could be related to the reported issue.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: the visualization issue of the catheter.Disconnect and reconnect the catheter and ensure good connection.If that does not resolve the problem, replace cable or the catheter.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(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 (stsf) and the biosense webster, inc.Product analysis lab observed a hole on the pebax.Initially, it was reported that towards the end of the procedure, the catheter would jump up and flipping back and forth when coming on ablation.The carto 3 system displayed an error code 339 "ref/deca: catheter eeprom error." the catheter was replaced, and the issue was resolved.The carto 3 system is operating per specs and is not responsible for the product issue.There was no patient consequence.The visualization issue was assessed as not mdr reportable.The device is not visualized by the carto system.The user will have to replace the catheter in order to complete the case.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.The eeprom data error was assessed as not mdr reportable.Since the device is unable to map with carto or the catheter cannot be visualized by the carto system, the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the biosense webster, inc.(bwi) product analysis lab received the device for evaluation and found that there was a hole on the pebax and reddish material inside of it.The hole on the pebax was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2021.

• 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
• MDR Report Key: 12505948
• MDR Text Key: 280841123
• Report Number: 2029046-2021-01591
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30513948M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN DECAPOLAR CATHETER; UNK_CARTO 3