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

Catalog Number D134804

Device Problems Material Puncture/Hole (1504); Failure to Sense (1559)

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

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

On 30-nov-2023, the product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.A magnetic sensor functionality test was performed and the device was recognized on the system; however, error 105 was displayed on the screen.The printed circuit board (pcb) was inspected and no errors were observed; however, the reddish material inside the pebax could be related to the 105 magnetic issues found.A manufacturing record evaluation was performed for the finished device 31085967l number, and no internal actions related to the reported complaint condition were identified.The magnetic issue reported by the customer was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.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.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) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, approximately 10 minutes in, there was magnetic interference on the ablation catheter displayed on the carto 3 system.The catheter was displayed on the carto 3 system was moving all over the place while the magnetic sensor error code activated.The cable was replaced with no resolution.When the catheter was replaced, the issue was resolved.The procedure continued and no patient consequences were reported.

Manufacturer Narrative

On 30-nov-2023, the product investigation was updated to include the manufacture date of 18-aug-2023.Section h4 has been updated accordingly.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) per internal review, it was identified that the h6 medical device problem code for "material puncture / hole" (a041001) due to the hole in the pebax was mistakenly omitted from the initial report.The code has been added to this report.

• 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: 18238983
• MDR Text Key: 329388824
• Report Number: 2029046-2023-02785
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31085967L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2023
• 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: CARTO 3 SYSTEM.