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

Catalog Number D134701

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Insufficient Information (3190)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The product was returned to biosense webster (bwi) for evaluation.Bwi conducted a visual inspection, and screening test of the returned device following bwi procedures.Visual analysis revealed foreign material on the tip area.In addition, the pebax was observed broken and the second electrode was observed damage (lifted).The device was connected to carto 3 and error 105 was observed due to an open circuit inside the shaft.Also, an irrigation issue was performed, and no water leakage was observed.Then, a scanning electron microscope (sem) was performed on the foreign material and oxidation per saline solution was identified.A manufacturing record evaluation was performed for the finished device number 31151275l, and no internal action was found during the review.The damage on the pebax could be related to the force issue.Therefore, the customer complaint was confirmed.The potential cause of the damage on the pebax could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The open circuit and the foreign material on the tip could be related to the handling of the device after procedure.However, this cannot be 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: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the damaged electrode (lifted).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 broken pebax.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: cable, electrical (g02004) were selected as related to the error 105 that was observed due to an open circuit inside the shaft.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the foreign material on the tip area.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf; d134701) for which biosense webster¿s product analysis lab (pal) identified foreign material on the tip area.In addition, the pebax was observed broken and the second electrode was observed damage (lifted).Initially, it was reported that after mapping the left atrium, they connected the stsf catheter to the patient interface unit (piu).From the beginning, the catheter¿s force and grams seemed to be wrong.They tried to zero the catheter¿s force both inside and outside the patient¿s body; however, it did not seem to work.Afterwards, they replaced the catheter cable with a new one and the problem was not resolved.They then removed the catheter from the patient¿s body, and they tried to detect if there was something stuck on the catheter¿s tip and to visually inspect the catheter¿s condition.That is when they noticed that the catheter¿s tip was ¿cutdown¿.They replaced the catheter cable with a new one and the problem was not resolved.Finally, they replaced the mapping catheter with a new one (d134701) and the problem eventually resolved.The procedure continued without any further incident and no harm to the patient.The force issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.Additional information was received which indicated that the damage did not result in wires being exposed nor in any lifted or sharp rings.There was no resistance nor difficulty during insertion or removal of the catheter.The issue was found at the very distal end of the catheter.The catheter was not pre-shaped.Clarification was requested on what they mean by ¿catheter¿s tip was cutdown¿ and the response was ¿the catheter' s tip was chopped.¿ with the information available, this event was assessed as not mdr reportable.However, when the biosense webster, inc.Product analysis lab received the device for evaluation, there was foreign material on the tip area.In addition, the pebax was observed broken and the second electrode was observed damage (lifted).This was assessed as mdr reportable.The awareness date for this reportable lab finding was 03-apr-2024.

• 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: 19081295
• MDR Text Key: 340683982
• Report Number: 2029046-2024-01179
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134701
• Device Lot Number: 31151275L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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: CBL, 34 HYP/34 LEMO, 10'; CBL, 34 HYP/34 LEMO, 10'; CBL, 34 HYP/34 LEMO, 10'; UNK_CARTO VIZIGO SHEATH