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 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 26-mar-2024.The device evaluation was completed on 02-apr-2024.The device was returned to biosense webster (bwi) for evaluation.The returned device's visual inspection and screening test were performed following bwi procedures.Visual analysis was performed, and the tip was observed bent and a hole was observed on the pebax component.Then, the device was connected to the carto 3 system, and it was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit in the tip area.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.The root cause of the open circuit inside the tip cannot be determined.The damage on the tip and pebax could be related to the manipulation of the device during procedure; however, this cannot be conclusively determined.The instruction for use (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.Explanation of codes: investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported ¿force issue¿.In addition, the biosense webster inc.Analysis finding of the ¿open circuit inside the tip¿.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 biosense webster inc.Analysis finding of the ¿tip was observed bent and a hole was observed on the pebax¿.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 on the pebax.Initially a force issue was reported.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 02-apr-2024, the tip was observed bent and a hole was observed on the pebax component.The event was originally considered non-reportable, however, bwi became aware of a hole on the pebax on 02-apr-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: 19191718
• MDR Text Key: 341731651
• Report Number: 2029046-2024-01373
• 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: 04/26/2024

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: D134721IL
• Device Lot Number: 31164948L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2023
• 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