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

Model Number D134805

Device Problems High Readings (2459); Communication or Transmission Problem (2896)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 13-oct-2021.The device evaluation was completed on (b)(6) 2021.The catheter was returned to biosense webster for evaluation.Bwi conducted a visual inspection and spi screening test of the returned catheter.Visual analysis of the returned catheter revealed reddish material inside and a hole on the pebax on the stsf catheter.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force could not be performed due to impedance failed.A failure analysis was performed and it was found that there is a loss of electrical resistance from the cut to the tip creating the impedance issue.The event described force issue was unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.A manufacturing record evaluation was performed and no non-conformance was found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.To minimize force issues, 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.(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.Product analysis lab observed a hole on the pebax.Initially it was reported when coming on ablation, the thermocool® smart touch® sf bi-directional navigation catheter was giving high force and would not give sur point values on the carto 3 system.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.The carto 3 system was operating per specifications and is not responsible for the product issue.The high force issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.The sur point values issues was assessed as a not mdr reportable carto error-catheter map issue.The potential risk was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2021 there was reddish material and a hole on pebax.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2021.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12930989
• MDR Text Key: 285829806
• Report Number: 2029046-2021-02096
• 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: 12/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30589186L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• 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 CATHETER; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE; UNK_CARTO 3