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

Model Number D134804

Device Problems Temperature Problem (3022); Material Split, Cut or Torn (4008)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 20-apr-2022.The device evaluation was completed on 12-may-2022.The device was returned to biosense webster for evaluation.Visual inspection and temperature and impedance test of the returned device were performed following biosense webster, inc.Procedures.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue.A temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.Note: the blood inside the pebax could be related to the issue reported by the customer; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.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 procedure with a thermocool® smart touch® sf bi-directional navigation catheter and biosense webster, inc.Product analysis lab observed a cut on the pebax with internal parts exposed.Initially it was reported that the smartablate generator was not displaying a temperature when the catheter was plugged into the patient interface unit (piu).They replaced the ablation cable without resolution.The ablation catheter was replaced and the issue was resolved.It was reported that the smartablate generator is operating per specifications and was not responsible for the product issue.The procedure was continued.There was no patient consequence reported.The temperature not displaying was assessed as not mdr reportable.The ablation cannot be performed since there is no radio frequency energy applied.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 12-may-2022 there was a cut on the pebax with reddish-brown material inside and internal parts exposed.The cut on the pebax with internal parts exposed was assessed as mdr reportable.The awareness date for this reportable lab finding was 12-may-2022.

• 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14627642
• MDR Text Key: 295815177
• Report Number: 2029046-2022-01223
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30695007L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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: UNKNOWN BRAND ABLATION CABLE; UNKNOWN BRAND ABLATION CABLE; UNKNOWN BRAND CATHETER; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR