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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 02/13/2021

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.When mapping, after about 30 minutes after the smart touch sf catheter was connected the patient experienced a pericardial effusion and the patient required extended hospitalization for one day for monitoring.It was reported that the patient¿s blood pressure decreased then an echocardiogram was performed to check for pericardial effusion which was confirmed.The event occurred when mapping, after about 30 minutes after the smart touch sf catheter was connected.No medical or surgical intervention was required.The patient required extended hospitalization for one day.Upon follow up the patient¿s condition was reported as improved.The physician opinion on the cause of this adverse event was the procedure.The physician considered that cardiac tamponade was likely caused by a rv catheter manufactured by another company.Since the event is life-threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

Manufacturer Narrative

Per internal review on 4/22/2021, it was determined that the pericardial effusion code does not apply.It was decided that the event was a cardiac tamponade and the health effect code has been updated accordingly in this supplemental report.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 11431453
• MDR Text Key: 240653683
• Report Number: 2029046-2021-00309
• 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: 02/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30457649M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening