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

Catalog Number D134721IL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/31/2023

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 07-feb-2024.The device evaluation was completed on 04-mar-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 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 electrical wires inside the tip.Also, the potential cause of the damage on the pebax could be related to the usage of the device during procedure; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device, and no internal actions was found during the review.The root cause of the force issue reported by the customer could be related to the insufficient adhesive and the damage on the pebax.Therefore, the force issue reported by the customer was confirmed.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.This product issue will be addressed through bwi's quality system.An internal corrective action has been opened to investigate to reduce this failure mode.Explanation of codes: -investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause traced to manufacturing (d03) / component code: adhesive (g0405201) were selected as related to the customer¿s reported ¿force¿ issue.-investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: adhesive (g0405201) were selected as related to the customer¿s reported ¿force¿ issue.-investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15)/ component code: sleeve (g04115) were selected as related to the customer¿s reported ¿force¿ issue.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the surface of the pebax.Initially it was reported a force issue.During the procedure, the force value could not be zeroed.A second device was used to complete the procedure.There was no adverse event reported on the patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 04-mar-2024, observed 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 04-mar-2024 and have assessed this returned condition as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 18988647
• MDR Text Key: 338733255
• Report Number: 2029046-2024-01032
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134721IL
• Device Lot Number: 31164823L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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