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 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a preface® guiding sheath with multipurpose curve and a thrombus issue occurred.During the ablation, thrombus was found at the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The same issue occurred with the preface® guiding sheath with multipurpose curve.The issues were resolved by replacing both devices and the procedure was completed without patient consequence.On 12/26/2019, biosense webster inc.(bwi) received additional information about the event.It was reported that the settings on the smartablate generator were set to the wrong setting by the medical engineer as non-irrigated 4mm catheter.After confirming the wrong setting, the physician removed the catheter and confirmed the thrombus.The issue was resolved by changing the devices.There was no report of patient consequence.The issue of thrombus formation on the devices has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

On 1/6/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found the dome was partially covered in dark red-brown material which was determined to be a thrombus formation on the ablation catheter dome.The finding is consistent with the customer¿s reported issue and continues to be considered an mdr reportable malfunction.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a preface® guiding sheath with multipurpose curve and a thrombus issue occurred.During the ablation, thrombus was found at the tip of the thermocool® smart touch® sf bi-directional navigation catheter.The same issue occurred with the preface® guiding sheath with multipurpose curve.The issues were resolved by replacing both devices and the procedure was completed without patient consequence.On 12/26/2019, biosense webster inc.(bwi) received additional information about the event.It was reported that the settings on the smartablate generator were set to the wrong setting by the medical engineer as non-irrigated 4mm catheter.After confirming the wrong setting, the physician removed the catheter and confirmed the thrombus.The issue was resolved by changing the devices.There was no report of patient consequence.Device evaluation details: the device evaluation has been completed.The device was inspected, and the top of the dome was partially covered in dark red / brown material.Then, during the second visual it was found to be thrombus on dome.The temperature was tested and no issues were observed.An irrigation test was performed, and it was found within specifications.The catheter was irrigating correctly.A manufacturing record evaluation was performed, and no internal action was found during the review.The customer complaint has been confirmed.The root cause of the clot reported by the customer could be related to the usage of the device during the procedure, however this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref #: (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: 9533888
• MDR Text Key: 200060656
• Report Number: 2029046-2019-04080
• 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,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30283784M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PREF.GUIDING SHEATH W/MULT.CRV.; SMARTABLATE GENERATOR KIT-WW.