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

Model Number D134805

Device Problems Material Puncture/Hole (1504); High Readings (2459); Electrical Shorting (2926)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was inspected and foreign material and a hole were found on the pebax component.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no errors appeared during the test.The force values and the vector were observed within specifications.No force issues were observed.However, the foreign material inside the pebax component could be related to the issues reported by the customer.A manufacturing record evaluation was performed for the finished device 30912547l number, and no internal actions related to the reported complaint condition were identified.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.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

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.The finding was identified on (b)(6) 2022.During the procedure, that the carto 3 system displayed high-force warnings when going on ablation and when the catheter was floating in the heart.They exchanged the cable and then they removed the catheter and inspected it and saw blood in the lumen of the catheter.The catheter was exchanged, and the issue was resolved.The replacement catheter displayed a current leakage error (7).The cable was exchanged, and the issue persisted.The ablation catheter was exchanged, and the issue was resolved.Patient has not exhibited any neurological symptoms since the procedure was completed.No patient consequences were reported.Biosense webster manufacturer's reference number (b)(4) has 2 reports.This report is for the replacement catheter.The one with the blood in the lumen was already reported in manufacturer report number 2029046-2022-03124.Current leakage-device disruption is not mdr-reportable.Hole in the pebax is mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-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: 16084578
• MDR Text Key: 308537478
• Report Number: 2029046-2023-00006
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30912547L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2022
• 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.; THERMOCOOL SMARTTOUCH.; VIZIGO SHEATH.