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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

"no code available" is being used for surgical intervention.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 male patient underwent cardiac ablation procedure for idiopathic ventricular tachycardia (idvt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that during an idvt case, a pericardial effusion was noticed.The patient came in with an already compromised conduction system and in the middle of the case had a drop in blood pressure.The pericardial effusion was confirmed by intracardiac echocardiography (ice).A pericardiocentesis was started but the medical intervention provided ended up being open heart surgery to find the source of the bleeding.The patient was reported to be in stable condition.The physician did not mention what they thought to be the cause of the effusion.The adverse event was discovered while a biosense webster product was in use.The patient¿s condition was improved.After going through open heart surgery, the patient required extended hospitalization.Since cardiac tamponade may be life threatening it is mdr-reportable.

Manufacturer Narrative

On 11/6/2020, bwi received additional information regarding the event.The adverse event was discovered while in biosense webster product was in use.Post ablation, mapping was continued because the arrhythmia was suppressed but not resolved.Physician¿s causality opinion was not provided.The patient¿s condition was improved.No transseptal was performed.Ablation was performed prior to the event but there was no evidence of steam pop.Default irrigation settings were used 7-15ml/min (device instructions for use recommends 8-15ml/min).No error messaged appeared on the bwi equipment during procedure.Graph, dashboard, vector and visitag were used for force visualization.The visitag stability settings were 2.5 mm stability range, 3 seconds, fot 25% 3 grams, 2 mm tag size.Tag index was used as prospective coloring option.After going through open heart surgery, the patient required extended hospitalization.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: 10742442
• MDR Text Key: 215488326
• Report Number: 2029046-2020-01554
• 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
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNK_TRANSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention