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

Catalog Number D133604IL

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

The 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, the photo does not provided sufficient information related to the deflection issue reported by the customer since the tip was observed relaxed with the piston down, and therefore no results can be obtained from it.Additionally, the product was returned to biosense webster (bwi) for evaluation.Visual inspection and cable testing were performed following bwi procedures.Visual analysis indicated that the tip of the device was cut.A deflection test was executed, and the curve deflected within specified parameters, without any deflection issues observed.It was concluded that the damage to the device's tip may be linked to the handling of the device after the procedure, however, this conclusion cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30992679m number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of the 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: (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular reentrant tachycardia ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the bwi product analysis lab identified that the tip of the device was cut.During the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.The deflection issue is not mdr-reportable.The cut tip is mdr-reportable.

• 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: 17954042
• MDR Text Key: 326294079
• Report Number: 2029046-2023-02349
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Catalogue Number: D133604IL
• Device Lot Number: 30992679M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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