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

Catalog Number D132705

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (b)(6) 2018.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent an abalation procedure for idiopathic ventricular tachychardia (idvt) with a thermocool smart touch bi-directional navigation catheter, and noise displayed on both carto 3 and recording system ablation signals when the ablation catheter was connected.The catheter was replaced and the issue resolved.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 has been assessed as not reportable.This event is being reported because the bwi failure analysis lab received the device on for evaluation and the (b)(6) 2018 fal findings from the scanning electron microscope (sem) showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.The finding of a hole in the pebax is has been assessed as a reportable malfunction.The awareness date has been reset to (b)(6) 2018.

Manufacturer Narrative

Additional information was received on 7/4/2018.The manufacture date: 2017/08/08 and expiration date: 2018/07/31 have been added to the corresponding fields of this report.Manufacturer ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an abalation procedure for idiopathic ventricular tachychardia (idvt) with a thermocool® smart touch¿ bi-directional navigation catheter, and noise displayed on both carto 3 and recording system ablation signals when the ablation catheter was connected.The investigational analysis was completed 11/14/2018.The device was visually inspected and reddish residue was found inside the pebax.No visual damages were found.Electrical testing was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, scanning electron microscope (sem) testing was performed on the damaged area and the results showed evidence of mechanical damage, stress marks, and a hole on the surface of the pebax.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 cannot be confirmed.The root cause of the damage on pebax cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer ref no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7642584
• MDR Text Key: 112893160
• Report Number: 2029046-2018-01739
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: D132705
• Device Lot Number: 17714558M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Date Manufacturer Received: 11/14/2018
• Patient Sequence Number: 1