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

Catalog Number D133604IL

Device Problems Material Puncture/Hole (1504); Failure to Sense (1559)

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

Event Date 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

The photo analysis and product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, alert 106 "force catheter sensor error" was observed on carto3 screen.Additionally, the device was returned to biosense webster (bwi) for evaluation.A visual inspection, screening test, and scanning electron microscope (sem) study of the returned device were performed in accordance with bwi procedures.Visual analysis revealed that the pebax was yellow, additionally, foreign white material and a hole in the pebax were found.A screening test was performed, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to a hole in the pebax.The sem study revealed that the white foreign material was partially composed of saline solution, as this substance is not used during the manufacturing process, the condition of the pebax may be related to the procedure; however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device 31096379m, and no internal action was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number.

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure, when the catheter was inserted into the carto3 machine, the system immediately showed a 106 error.A second device was used to complete the operation.There was no adverse event reported on patient.Catheter was not used in patient. .

• 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: 18314965
• MDR Text Key: 330466586
• Report Number: 2029046-2023-02926
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

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: D133604IL
• Device Lot Number: 31096379M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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: CARTO 3 SYSTEM