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

Model Number D134804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ((b)(6), 102kg, 4 cm aortic arch aneurysm, enlarged left atrium) underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.It was reported by the caller that the patient suffered a pericardial effusion.There was no evidence of effusion before the procedure.The caller stated that they had performed a cavotricuspid isthmus (cti) line, completed the pulmonary vein isolation (pvi), performed cardioversion, roofline, and mitral line.The physician removed all catheters, and when they removed the sheaths, anesthesia noticed a sudden drop in blood pressure (50/30).A pericardiocentesis was performed and 1000 ml of fluid was removed.At that time, the physician requested assistance from cardiovascular operation room (cvor), and the patient was hemodynamically stable but taken into surgery.A tear along the inferior vena cava and right atrium junction was repaired.Extended hospitalization was required.The patient fully recovered by 10/21/2020.The opinion of the physician is that the cause of the event was procedure and patient condition.The physician has stated that they feel that after he pulled the catheters and sheaths from the left atrium and into the right atrium, he failed to look at both an anterior and lateral view to get full orientation of sheath.In routine maneuver to check if the cti (cavotricuspid isthmus) line needed further ablation or not, he feels he must have swiped too far and caused damage to ivc area.He does not feel catheters or sheaths were faulty.The event occurred post use of biosense webster products.The maximum ablation power used was 30w.A total of 126 lesions were applied.Total ablation time was 34min and 29sec (615ml of fluid used).Transseptal was performed with brk needle (st.Jude).There was no evidence of steam pop.The irrigation flow was set to 2ml/min for mapping and to 8ml/min during ablation.Graph, vector, dashboard and surpoint were used for force visualization.The visitag stability parameters were set to 2.5mm for 3 sec, force 25% at 3 grams and tag size 3mm.Ablation index was used as a prospective color option.There were no error messages observed on biosense webster equipment during the procedure.

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2020.It was reported that a female patient (64 year old, 102kg, 4 cm aortic arch aneurysm, enlarged left atrium) underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter.It was reported by the caller that the patient suffered a pericardial effusion.There was no evidence of effusion before the procedure.The caller stated that they had performed a cavotricuspid isthmus (cti) line, completed the pulmonary vein isolation (pvi), performed cardioversion, roofline, and mitral line.The physician removed all catheters, and when they removed the sheaths, anesthesia noticed a sudden drop in blood pressure (50/30).A pericardiocentesis was performed and 1000 ml of fluid was removed.At that time, the physician requested assistance from cardiovascular operation room (cvor), and the patient was hemodynamically stable but taken into surgery.A tear along the inferior vena cava and right atrium junction was repaired.Extended hospitalization was required.The patient fully recovered by (b)(6) 2020.The device was visually inspected, and it was found in good normal conditions.The magnetic, temperature and force features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The catheter passed specification.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: 10826931
• MDR Text Key: 216611806
• Report Number: 2029046-2020-01683
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30419903M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; BI DIR 7FR DEF CS,F-J,12 PIN; CARTO 3 SYSTEM; NON BWI-ST. JUDE BRK NEEDLE; PENTARAY NAV ECO 7FR, F, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 102