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 Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12-mar-2024.The device evaluation was completed on 19-mar-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test evaluation of the returned device was performed following bwi procedures.Visual analysis revealed reddish material was observed in the pebax; however, no damage was found.For this reason, a scanning electron microscope (sem) analysis was requested and a hole was observed.The force feature was tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The reddish material inside the pebax could be related to the force issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.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 on the pebax.Initially it was reported high force when ablating/when flushing level increased.Removed catheter from the patient and tried to flush.Blood was observed in the transparent part of the catheter tip where the force spring is located.Changed catheter and the procedure continued.The procedure was not delayed due to the reported event.The procedure was successfully completed.No patient consequence reported.Additional information was received.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.No information if the catheter pebax was physically damaged.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 19-mar-2024 reddish material was observed in the pebax; however, no damage was found.For this reason, a scanning electron microscope (sem) analysis was requested and a hole was observed.This event was originally considered non-reportable, however, bwi became aware of a hole on 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: 19103157
• MDR Text Key: 340901183
• Report Number: 2029046-2024-01224
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 31195408L
• 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: 11/30/2023
• 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: 8.5F SHEATH WITH CURVE VIZ SMC.