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

Model Number D134805

Device Problems Erratic or Intermittent Display (1182); Material Split, Cut or Torn (4008)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.(bwi) product analysis lab received the device on 4/20/2021.The device evaluation was completed on 5/19/2021.Visual analysis of the returned catheter revealed reddish material inside and a cut in the pebax on the thermocool® smart touch® sf bi-directional navigation catheter.Carto test was performed in accordance with bwi procedures.The returned sample was connected to the system and no error was displayed on the screen.A manufacturing record evaluation was performed for the finished device 30487722m number, and no internal action 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 the pebax damage cannot be established.It should be noted that for product visualization failure, the instructions for use contain the following warning stated in the carto 3 system manual: if you cannot determine the orientation or deflection of the catheter(s) from the visual representation of the catheter on the carto® 3 system screen, refer to the fluoroscopic image of the catheter.The event described could not be confirmed as the device performed without any carto issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent an atrial flutter right (r-afl)) procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the biosense webster inc, (bwi) product analysis lab observed a cut on the pebax with reddish-brown material inside and internal parts exposed.Initially, it was reported that the image of the stsf catheter was jumping around on the carto 3 system when they came on ablation.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved.No adverse patient consequences were reported.The icon jumping issue was assessed as not mdr reportable.Catheter icon jumping is highly detectable issue.There is no real movement of the catheter.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 on (b)(6) 2021 that there was a cut on the pebax with reddish-brown material inside and internal parts exposed.This finding 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11995779
• MDR Text Key: 265992392
• Report Number: 2029046-2021-00926
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30487722M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• 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