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

Model Number D134805

Device Problems Material Puncture/Hole (1504); High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, reddish material was observed inside the pebax, however, there is no evidence of physical damage on the pebax, the reddish material observed inside the pebax could be related to the customer complaint, however, this cannot be conclusively determined at this time.Visual analysis of the returned sample revealed foreign material inside the pebax on the smart touch bidirectional sf device.The magnetic sensor functionality was tested on carto, and the device failed.Errors 105 and 106 were observed.The device was dissected on the tip area; loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.The device was inspected on the pebax area, under microscopy, to identify if there was damage on the pebax, that caused the foreign material inside the pebax.A hole was found in the pebax.The damage in the pebax could be related to excessive force or to the shipment process.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the device is disconnected.If the problem persists, replace the device cable or the device.A manufacturing record evaluation was performed for the finished device number: 30799813l, and no internal actions related to the complaint were found during the review.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

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax with foreign material inside.The finding was identified on (b)(6) 2022.It was initially reported by the customer that the carto 3 system was displaying a high alert when they would try to ablate.The catheter was rezeroed while free-floating.The catheter was free-floating using intracardiac echocardiography (ice).To troubleshoot the cable was replaced without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.No patient consequences were reported.High force is not mdr-reportable.Foreign material inside the pebax (with no external damage) is not mdr-reportable.Hole in the pebax is mdr-reportable.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15613391
• MDR Text Key: 307071011
• Report Number: 2029046-2022-02549
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2022

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30799813L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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