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

Catalog Number D134721IL

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

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post procedure the bwi product analysis lab identified a hole in the pebax.During the procedure itself, a force sensor error (error 106) was identified.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.The sensor error is not mdr-reportable.The hole in the pebax is mdr-reportable.

Manufacturer Narrative

The photo analysis and product investigation were 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 force sensor issue reported by the customer, and therefore no results can be obtained from it.Additionally, the device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed that the pebax area was observed yellowish with a hole.No foreign material was observed inside.No other physical damage was observed.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit in the tip area.This could be related to the damage observed in the pebax area.The potential cause of the damage on the pebax could be related to the procedure.A manufacturing record evaluation was performed for the finished device [31029779l] number, and no internal actions related to the reported complaint condition were identified.  the force 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: (b)(4).

• 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: 18094969
• MDR Text Key: 328503056
• Report Number: 2029046-2023-02581
• 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: 11/08/2023

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 Expiration Date: 05/19/2024
• Device Catalogue Number: D134721IL
• Device Lot Number: 31029779L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2023
• 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