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

Catalog Number D134805

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 12-mar-2024.The device evaluation was completed on 19-mar-2024.The smart touch bidirectional sf device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material and a hole in the pebax.The magnetic and force features were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The blood found inside the pebax area may contribute to the force and magnetic issue reported.The root cause of the hole in the pebax could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed and no internal action was found during the review.The issue reported by the customer was confirmed.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially it was reported that ablation was started and contact force became ¿hi¿.When the catheter was removed from the cardiac cavity, blood was found inside the tip of the catheter.Timing occurred during right superior pulmonary vein (rspv) ablation (approximately 1 hour after catheter use).Cable was replaced but the issue continued.This issue was resolved by replacing the thermocool® smart touch® sf bi-directional navigation catheter to another new one.The procedure was successfully completed without patient consequence.Additional information was received.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was not physically damaged.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 19-mar-2024 there was reddish material and a hole in the pebax.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax on 19-mar-2024 and have assessed this returned condition as reportable.

• 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: 19103147
• MDR Text Key: 340802721
• Report Number: 2029046-2024-01223
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 31164973L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• 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: AGILIS, S CURVE, 8.5 FR.; UNK CABLE.