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

Catalog Number D134805

Device Problems High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter right (r-afl) ablation 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 surface with reddish material inside the pebax.Initially, it was reported that the carto 3 system alerted that the catheter needed to be re-zeroed several times after being connected.The biosense webster (bwi) representative stated that shortly after, there was an impedance spike on the carto 3 system.The spike did not align with where they were at the time.The cable was replaced with no resolution.They removed the catheter from the body to check for char when they noticed blood inside the tip of the catheter in the "sensor area".When the catheter was replaced, the issue resolved.No adverse patient consequences were reported.The foreign material inside the pebax - no external damage issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found a hole on the surface with reddish material inside the pebax.This finding was assessed as mdr reportable.The awareness date for this reportable lab finding is (b)(6) 2023.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on (b)(6) 2023.The device evaluation was completed on (b)(6) 2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Visual inspection was performed and a hole on the surface with reddish material inside the pebax was observed.The temperature and impedance test were performed and the device was found working correctly.No temperature or impedance issues were observed.The hole on the surface could be related with the manipulation of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 31049476l number, and no internal actions related to the reported complaint condition were identified.The issues reported by the customer were confirmed.The foreign material inside the pebax could be the root cause of the high impedance reported by the customer.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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).

• 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: 17515748
• MDR Text Key: 321182491
• Report Number: 2029046-2023-01769
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31049476L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• 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: UNK BRAND CABLE; UNK_CARTO 3