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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Material Puncture/Hole (1504)

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

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed foreign material inside the pebax on the smart touch bidirectional sf device.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.An electrical test was performed, and no electrical issues were found.It should be noted that device failure is multifactorial.Even though no electrical error was present during the screening test, contact of blood with the sensor wires can trigger errors.The instructions for use contain the following precautions: flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device [30727207l] number, and no internal actions related to the reported complaint condition were identified.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.The finding was identified on 18-may-2022.It was initially reported by the customer that during the case there was noise on the ablation signal and then the caller reported that caused "a full ekg blowout" (electrocardiogram) on both the carto 3 system and the recording system.To troubleshoot, the cable was replaced and the issue persisted, the catheter was replaced and the issue was resolved.The case continued.No patient consequences were reported.Hole in the pebax is mdr-reportable.Bad/partial ecg is not mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETE
• 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: 14672718
• MDR Text Key: 298590230
• Report Number: 2029046-2022-01270
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30727207L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2022
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2022
• 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; CARTO RECORDING SYSTEM