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

Catalog Number D133602

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device was visually inspected and sharp edge was observed on ring #1 and foreign material was stuck underneath sharp edge.Electrical testing was performed and the catheter failed.No electrical readings were observed on electrode #2.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.Fourier transform infrared spectroscopy test (ftir) was performed and the results showed that foreign material is presumably composed of polyamide with barium sulfate.This composite material is widely used as radio pacifier along medical device industries.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage, scratches and a sharp edge on the surface of the electrode.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During the manufacturing process, inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed.The root cause of the electrical wire breakage and the damage observed on the electrode cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Concomitant medical products: carto 3 system (model#: fg-5400-00c, serial#: unknown).Manufacturer ref no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for right atrial tachycardia, and noise was observed on the carto 3 system and the recording system.There was no signal interference observed on any other channels and the defibrillating signal was available for the physician to monitor the patient¿s heart rhythm.The catheter was replaced and the issue resolved and the procedure was completed without patient consequence.The potential it could cause or contribute to a serious injury or death is remote.Therefore, the observed noise was assessed as not reportable.This event is being reported because the bwi failure analysis lab received the device for evaluation and the (b)(6) 2018 fal findings of a sharp edge observed on ring electrode 1, approximately 0.5 cm from the distal tip.Additionally, white colored foreign material was stuck underneath the sharp edge.Therefore, sharp electrode ring edges and foreign material has been assessed as reportable.

• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7658965
• MDR Text Key: 113310880
• Report Number: 2029046-2018-01756
• 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: 06/06/2018

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: 11/21/2018
• Device Catalogue Number: D133602
• Device Lot Number: 17758654M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1