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

Catalog Number D133602

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis was completed on 5/16/2019.The device was inspected and it was found in normal conditions.During the second visual inspection, foreign material was observed under the ring #2.Electrical testing was performed on the catheter and it was found to be within specifications.No electrical malfunction was observed.The catheter was tested on the generator.Both the temperature and impedance values were observed within specifications.Cool flow pump testing was performed and was found within specifications.The catheter was irrigating correctly.No irrigation issues were observed.The magnetic sensor functionality was tested on carto.The catheter was properly visualized and no errors were observed.The force sensor feature was tested and it was working properly.The force values were observed within specifications.Scanning electron microscope testing was performed on the ring area.Results showed that the ring 2 was lifted and separated from the polyurethane border.However, the ring maintained its integrity.It is possible that the damage was caused by an unknown object.No other anomalies were observed.Fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the white particle is primarily composed of polyethylene and barium sulfate based material.This composite material is widely used as radio pacifier along medical device industries.On 5/13, a manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was not confirmed.The root cause of the ring damage with foreign material underneath cannot be related to the manufacturing process, since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure.However, this cannot be conclusively determined.Manufacturer's reference no: (b)(4).

Event Description

It was reported that after an ablation procedure for atrial right flutter with a thermocool® smart touch¿ electrophysiology catheter (stsf) the biosense webster inc.(bwi) product analysis lab (pal) found foreign material under ring 2 and electrode 2 lifted.Initially, it was reported that when the coronary sinus catheter was used, pacing from both electrodes 7 and 8 and noise occurred.The 12 lead electrocardiograms were unreadable.Additionally, it was reported that the stsf catheter temperature reading and force were incorrect.The temperature would go above 40c when trying to ablate.The catheter was re-zeroed multiple times, and the issue persisted.The cable was replaced with no resolution.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed noise, high temperature, and force issues have been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 4/6/2019, the bwi pal received the device for evaluation.Upon initial inspection, no visual damage or anomalies were observed.The bwi pal performed a second visual inspection on 5/6/2019 and found foreign material under ring 2.The observed foreign material has been assessed as mdr reportable.The awareness date has been reset to 5/6/2019.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8641960
• MDR Text Key: 146361682
• Report Number: 2029046-2019-03180
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Catalogue Number: D133602
• Device Lot Number: 30149589M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2019
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2018
• 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