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

Catalog Number D134805

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual inspection was performed, and a damage like a crack was observed on pebax's surface with reddish material inside it.The damage on the pebax, could be related to the manipulation of the device during the procedure, however, this can not be conclusively determined.The device was connected to carto 3 system and the it was recognized correctly; however, the device was not visualized since error 105 appeared due to the damage on the pebax.A manufacturing record evaluation was performed for the finished device 31147799l number, and no internal action related to the complaint was found during the review.The issues reported by the customer were confirmed.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.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 - persistent ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified a crack on the pebax with reddish material inside.During the procedure, the patient was prepped and draped in the normal fashion.The thermocool® smart touch® sf bi-directional navigation catheter was advanced into the left atrium via transseptal puncture.A map of the left atrium was created with the pentaray mapping catheter.The thermocool smart touch was zeroed in the left atrium.The physician placed the thermocool smart touch on the anterior wall of the left superior pulmonary vein to start ablation.On ablation the force increased to 87g after 2 seconds and the catheter interaction icon was displayed.The physician confirmed that the pentaray was in the right sided pulmonary veins and therefore not interacting with the thermocool smart touch.The catheter was re-zeroed.The physician tried to ablate on the posterior wall, but after 2 seconds the force still increased to 87g.The catheter cable was replaced.The physician tried to ablate again and the same force issue remained.After a 7 minute surgical delay, the catheter was replaced.The new catheter was zeroed and there were no issues on ablation.The case proceeded without further issues.No patient consequences were reported.

• 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: 18833014
• MDR Text Key: 337313105
• Report Number: 2029046-2024-00719
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2023
• 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: PENTARAY CATHETER