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

Model Number D134805

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

On 11/5/2019, the biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation.Upon receipt, reddish-brown material was found on the dome.On 11/7/2019 a second visual inspection confirmed the initial findings of reddish-brown material on the dome.These findings coincide with what was reported.Further testing was then performed.The investigational analysis completed 11/12/2019.The returned device was inspected and reddish brown material was observed on the catheter dome.During the second visual it was clarified that the material observed on the tip was the thrombus, reported by the customer.Per the event, the catheter was tested for electrical performance and stockert compatibility.It was found to be within specifications.Cool flow pump testing was then performed and it was found to be within specifications.A patency test was performed.It was determined that not all the holes were irrigating.This is related to the thrombus observed, since this material was obstructing the dome holes.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of the thrombus reported 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 use of the device during the procedure.However, this cannot be conclusively determined.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter, and a thrombus issue occurred.During the procedure, a steam pop occurred at the roof of the left superior pulmonary vein.The stsf catheter was removed and thrombus was observed attached to the tip.Catheter replacement resolved the issue and the procedure was completed.No adverse patient consequences were reported.The observed steam pop has 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.The thrombus issue has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter, and a thrombus issue occurred.During the procedure, a steam pop occurred at the roof of the left superior pulmonary vein.On 12/25/2019, additional information was received indicating a steam pop occurred while ablating in the roof of left superior pulmonary vein.There were no error messages.When the stsf catheter was removed, thrombus had attached to the tip.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The complaint product(s) will be returned for analysis.There was no report of patient consequence.Manufacture reference no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 9339045
• MDR Text Key: 194798418
• Report Number: 2029046-2019-03890
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

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: 07/18/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30252053M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/25/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1