MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

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

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax area with reddish material inside.In addition, electrode # 2 was observed lifted and a wire exposed.It was initially reported by the customer that during the operation, there was a problem with the force of the catheter.A second device was used to complete the operation.There was no adverse event reported on patient.The customer's reported force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax area with reddish material inside.In addition, electrode # 2 was observed lifted and a wire exposed.These findings were reviewed and assessed the issues of a ¿hole¿ in the pebax and lifted electrode as mdr reportable malfunctions since the integrity of the device was compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.The device was inspected, and it was found with a hole in the pebax area with reddish material inside.Also, electrode # 2 was observed lifted and a wire exposed.A screening test was performed, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit at the tip.The hole on the pebax area may be related to the force failure; however, the root cause of the hole may be related to handling of the device outside the manufacturing facilities as it was found that the white foreign material is partially composed of saline solution and this substance is not used during the manufacturing process; nevertheless, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The 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: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: 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 hole in the pebax identified by bwi pal.Investigation findings: open circuit (c0205): investigation conclusions: cause not established (d15): component code: sensor (b)(6) were selected as related to the customer's reported force issue.Investigation findings: stress problem identified (c0706): investigation conclusions: cause not established (d15): component code: electrode (g0201501): were selected as related to the lifted electrode identified by bwi pal.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 18531957
• MDR Text Key: 333488287
• Report Number: 2029046-2024-00192
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31064996M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• 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