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

Model Number D134702

Device Problems Erratic or Intermittent Display (1182); Material Puncture/Hole (1504)

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

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed a reddish material and a hole at the pebax section.A magnetic sensor functionality test was performed, and a jumping icon was observed on the system due to an internal pcb (printed circuit board) failure.The root cause of the pebax damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The magnetic issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

A patient underwent an atrial fibrillation (afib) 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.It was initially reported by the customer that that when coming on for ablation, the visualization of the catheter icon would jump on the screen, on the carto 3 system.The caller believes that error 401, map points cannot be acquired, may have also been displayed on the carto 3 system, but they were unable to confirm this.The grounding pads were replaced without resolution.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure continued.The caller reported carto 3 system is operating per specs and is not responsible for the product issue.There was no patient consequence.The customer¿s reported ¿jumping icon¿ issue is not an mdr reportable issue since the 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.On (b)(6) 2022, the bwi pal revealed that a visual inspection of the returned device found a reddish material and a hole in the pebax.This finding was reviewed and determined the issue of a hole in the pebax is an mdr reportable malfunction since the integrity of the device has been compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 2-jun-2022 and re-assessed it as mdr reportable.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14858598
• MDR Text Key: 297213069
• Report Number: 2029046-2022-01474
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: 06/29/2022

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 Expiration Date: 01/24/2023
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30707819L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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: CARTO 3 SYSTEM