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

Catalog Number D134721IL

Device Problems Display or Visual Feedback Problem (1184); Failure to Sense (1559)

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

Event Date 08/29/2023

Event Type  malfunction  

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 magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed; however, the hole could be related to the handling after the procedure but, it cannot be conclusively determined.The device was connected to the carto 3 system and it was recognized and visualized correctly.No issues or errors were observed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The issues reported by the customer could not be replicated, however, the reddish material on the pebax could be related to these issues, therefore, the complaint was confirmed.It should be noted that product failure is multifactorial.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 ref.# (b)(4).

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 for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that during the operation, the magnetic sensor issue/error was displayed, and then device was recognized by the carto but the catheter was not visualized on the carto system, or the visualization of the device disappeared or was not clear.A second device was used to complete the operation.There was no adverse event reported on patient.The customers¿ reported magnetic sensor and visualization issues are not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 26-oct-2023, the bwi pal revealed that a visual inspection of the returned device found a reddish brown material inside and a hole on the pebax with internal parts exposed.These findings were reviewed and assessed the issue of a ¿hole¿ in the pebax as an mdr reportable malfunction since the integrity of the device has been compromised.

• 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: 18172400
• MDR Text Key: 328556690
• Report Number: 2029046-2023-02705
• 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: 11/20/2023

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: D134721IL
• Device Lot Number: 31095290L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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