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

Catalog Number D134702

Device Problem Image Orientation Incorrect (1305)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported 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 on the pebax surface.Initially it was reported that the catheter force vector displayed inappropriately jumping around on the carto 3 system display.No errors were displayed.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure continued without further incident or harm.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024, observed reddish material inside the pebax.Due to the reddish material inside the pebax, the device was inspected under a microscope and a hole was found on the pebax surface.The event was originally considered non-reportable, however, bwi became aware of a hole on the pebax surface on 25-mar-2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2024.The device evaluation was completed on (b)(6) 2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, microscopic inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material inside the pebax.Due to the reddish material inside the pebax, the device was inspected under a microscope, and it was found a hole on the pebax surface.Then, 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.A manufacturing record evaluation was performed, and no internal action was found during the review.The reddish material inside the pebax could be related to the force issue reported by the customer; therefore, the customer complaint was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) 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.For the damage on the pebax the ifu 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, 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.Manufacturer¿s reference number: (b)(4).

• 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: 19102191
• MDR Text Key: 340804078
• Report Number: 2029046-2024-01221
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Device Lot Number: 31056548L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• 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: UNK CABLE; UNK_CARTO 3