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

Catalog Number D134805

Device Problems Display or Visual Feedback Problem (1184); 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 (b)(6) 2024.The investigation was completed on (b)(6) 2024.A picture was received for evaluation following biosense webster's procedures.According to the picture provided, a reddish material was observed inside the pebax; however no external damages were observed on the device.This condition could be related to the reported jumping icon issue by the customer.However, this cannot be conclusively determined.The customer complaint was confirmed based on the picture received.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed no bent in the tip; however, reddish material and a separation between the pebax and the electrode were observed.The device was connected to the carto 3 system and it was recognized and visualized correctly.No issues or errors 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 visualization issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage to 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.Explanation of codes: -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the photo provided.-investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿visualization issue¿ and the ¿reddish material observed inside the pebax¿ in the picture provided.Investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the ¿visualization issue¿ and the ¿reddish material was observed inside the pebax¿ in the picture provided.In addition, the biosense webster inc.Analysis finding of the ¿reddish material and a separation between the pebax and the electrode¿.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a separation between the pebax and the electrode.During ablation, the catheter begins to ¿jump¿ in the visualization.Replacing the neutral electrode and catheter cable did not resolve the problem.The problem only occurred at the end of the procedure.No risk to the patient.No error shown on the system.Tip of the catheter seemed to be slightly bent after the procedure.No patient consequence.Additional information was received.There was difficulty experienced while maneuvering the catheter.The pebax was bent, but not broken.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024 observed reddish material and a separation between the pebax and the electrode.This event was originally considered non-reportable, however, bwi became aware of a separation between the pebax and the electrode on (b)(6) 2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s reference number: (b)(4) the device investigation was reopened to clarify/correct the investigation findings which resulted in the following updated investigation on 08-may-2024: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed no bent in the tip; however, reddish material and a separation between the pebax and the electrode were observed.The device was connected to the carto 3 system and it was recognized and visualized correctly.No visualization issues or errors 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 foreign material and visualization issues reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the pebax damage cannot be determined.The instructions for use states: when cleaning the tip electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode, or may damage the contact force sensor.In addition, in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.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.An internal corrective action has been opened for further investigation of the force sensor sleeve insolation to prevent fluids to get inside into the device.Explanation of codes for the device evaluataion: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the ¿visualization issue¿ and the ¿reddish material was observed inside the pebax¿ in the picture provided.In addition, the biosense webster inc.Analysis finding of the ¿reddish material and a separation between the pebax and the electrode¿.In addition, during an internal review on 09-may-2024, noted a correction to the 3500a as in error omitted in h6.Type of investigation "analysis of data provided by user/third party".

• 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: 19016246
• MDR Text Key: 339356902
• Report Number: 2029046-2024-01094
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• 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: 31210673L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2024
• 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 CATHETER CABLE; UNK_CARTO VIZIGO SHEATH