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 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation 20-dec-2023.The device evaluation was completed on 23-jan-2024.The 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 revealed reddish material and a hole in the surface of the pebax.A screening test was performed and the device was recognized and visualized correctly; however, negative force vector appeared in the system with high force readings due to insufficient adhesive application on the wires inside the tip.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The force issue reported by the customer was confirmed since the insufficient adhesive and reddish material could be related to the issue reported.The root cause of the damage in the pebax could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: 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.Zero the contact force reading when moving the catheter from one chamber of the heart to another or upon reinsertion.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 to reduce this failure mode.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿blood was visualized inside of the tip of the catheter¿ and ¿high force readings¿.In addition, related to the biosense webster inc.Analysis finding of the ¿reddish material and a hole in the surface of the pebax¿.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: adhesive (g0405201) were selected as related to the customer¿s reported ¿blood was visualized inside of the tip of the catheter¿ and biosense webster inc.Analysis finding of the ¿insufficient adhesive application on the wires inside the tip¿.Investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: adhesive (g0405201) were selected as related to the biosense webster inc.Analysis finding of the ¿insufficient adhesive application on the wires inside the tip¿.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation 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 surface of the pebax.The ablation catheter displayed high force readings on the carto 3 system after zeroing appropriately.No errors were displayed.Blood was visualized inside of the tip of the catheter when removed from the patient.The ablation cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure was continued without further incident or harm.Additional information was received.Medium vizigo sheath was used in the procedure.There was no difficulty maneuvering or removing the catheter.They did not see damage at the catheter tip; rather just blood inside the coating.It may have been damaged and just smaller than they could detect visually.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 23-jan-2024, there was reddish material and a hole in the surface of the pebax.This event was originally considered non-reportable, however, bwi became aware of a hole in the surface of the pebax on 23-jan-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: 18708287
• MDR Text Key: 335976873
• Report Number: 2029046-2024-00503
• Device Sequence Number: 1
• Product Code: LPB
• 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: 02/14/2024

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: 31089700L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2023
• 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 MDC; UNK ABLATION CABLE; UNK_CARTO 3