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)

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

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed reddish material inside and a hole on the pebax of the device.A screening test was performed, and the device was visualized and recognized correctly; however, error 106 appeared on the system.The blood that was found inside the pebax area could be related to the reported issue.A manufacturing record evaluation was performed for lot 30759657l and no internal actions related to the reported complaint condition were identified.The evaluation determined that the cause of the pebax damage failure cannot be established.The blood inside the pebax area found could be related to the reported issue.According to the instructions for use, the following guidelines should be followed: in order to achieve optimal force reading accuracy and stability, allow the catheter to warm up for 2 minutes after connection to the carto¿3 system, prior to use of the force feedback feature.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster inc, (bwi) product analysis lab observed a hole on the pebax.Initially, it was reported that when engaging ablation on the thermocool smarttouch® sf, the catheter would immediately show high force.The catheter was re-zeroed 3 times and the issue continued.The reprocessed cable was replaced with a new one, without resolution.The catheter was replaced, and the issue was resolved, and the case continued.The issue was catheter-related.The smartablate® generator is operating per specs and was not responsible for the product issue.No adverse patient consequences were reported.The force high issue was assessed as not mdr reportable.The issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and visual analysis of the returned device revealed reddish material inside and a hole on the pebax.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15332957
• MDR Text Key: 305603859
• Report Number: 2029046-2022-02063
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30759657L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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: UNK BRAND CABLE; UNK BRAND CATHETER; UNK BRAND REPROCESSED CABLE; UNK_SMARTABLATE GENERATOR