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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30427242m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.After pvi, while ablating the cavotricuspid isthmus (cti) with the thermocool® smart touch® sf bi-directional navigation catheter, a steam pop occurred.The patient¿s blood pressure was then dropped, and cardiac tamponade was confirmed.Pericardiocentesis was performed to drain the fluid from the pericardial space; however, despite draining for about an hour, the effusion did not stop.The patient was transferred to open-heart surgery.On 12/3/2020, additional information was received that the patient was in stable condition.Physician causality opinion was not provided; however, physician mentioned no device deficiencies were observed while using the product.It is unknown if the patient required of extended hospitalization.No bwi product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(6) on 12/28/2020, it was noticed that the health effect - impact code of "surgical intervention" was inadvertently omitted in the 3500a initial medwatch report.

Manufacturer Narrative

On 2/15/2021, biosense webster inc.Received additional information indicating the patient is male.The outcome of the adverse event is improved.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: 11078075
• MDR Text Key: 223799056
• Report Number: 2029046-2020-01993
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30427242M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO SMS 8F CATHETER; CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention