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 Problem Pericardial Effusion (3271)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

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 patient underwent an atrial tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered pericardial effusion requiring surgical intervention.The patient was admitted for atrial tachycardia.The procedure was planned with local sedation (no ga - general anesthesia).This is a redo from a previous ablation procedure performed in (b)(6) 2021.Right after doing the transseptal, a pericardial effusion (pe) occurred, and the patient required surgical intervention to stop the hemorrhage.Patient had a sternotomy with stitched on the left atrial roof to fix a hole of 2mm.The physician¿s opinion regarding the cause of this adverse event is that this is procedure and patient condition related.Before the procedure, the patient was considered fragile with extensive medical records.The physician did not perform a transseptal puncture (foramen oval).Prior to noting the pe, ablation was not performed.There was no evidence of a steam pop because no ablation was performed.The event occurred at the beginning of the mapping phase.The stsf was in low irrigation mode (2ml/min).Regarding the pump, since no energy was delivered, the mode remained in low irrigation flow.The correct catheter settings were selected on the generator; however, it was reported that the generator was not used.No error messages were observed on the biosense webster equipment during the procedure.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 25-sep-2021.The device evaluation was completed on 5-oct-2021.It was reported that a patient underwent an atrial tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered pericardial effusion requiring surgical intervention.The patient was admitted for atrial tachycardia.The procedure was planned with local sedation (no ga - general anesthesia).This is a redo from a previous ablation procedure performed in (b)(6) 2021.Right after doing the transseptal, a pericardial effusion (pe) occurred, and the patient required surgical intervention to stop the hemorrhage.Patient had a sternotomy with stitched on the left atrial roof to fix a hole of 2mm.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.The magnetic, temperature, and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30571481l number, and no internal action related to the complaint was found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instruction for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12373365
• MDR Text Key: 268354364
• Report Number: 2029046-2021-01404
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30571481L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2021
• Date Manufacturer Received: 09/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-WW; UNK_CARTO 3; UNK_SMARTABLATE PUMP; SMARTABLATE GENERATOR KIT-WW; UNK_CARTO 3; UNK_SMARTABLATE PUMP
• Patient Outcome(s): Required Intervention