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); Pseudoaneurysm (2605)

Event Date 11/23/2020

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 (male, (b)(6)) underwent cardiac ablation procedure for idiopathic ventricular tachycardia (idvt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and pseudoaneurysm requiring surgical intervention.It was reported by the caller that during the premature ventricular contraction (pvc) ablation procedure, the intracardiac echo (ice) catheter (soundstar) was used to confirm a pericardial effusion.The patient was stable.A pericardiocentesis was performed and 400ml of fluid were removed.At the time of the effusion, the case was close to being completed and was concluded.The patient stayed overnight for observation.The physician did not state if the catheter was the cause of the adverse event.The effusion was noted towards the end of the pvc ablation while all catheters were being used.Upon reviewing the case with the physician, she believes it was due to the location of the pvc ring in a thin walled area, it necessarily due to catheter failure.The patient went to the operation room for a surgical repair of a pseudoaneurysm.The patient¿s condition has improved.As of (b)(6) 2020, the patient was hospitalized from the procedure the day before.Transseptal was performed with baylis nrg needle.There was no evidence of steam pop.Irrigation settings were 2ml/min during mapping and 15ml/min during ablation.There were no error messages observed on biosense webster, inc.Equipment during the procedure.Dashboard, vector and visitag were used for force visualization.The visitag settings were tag size 3mm, 2.5 mm for 3seconds, over 3g 25% of the time.Surpoint value was used for coloring option.The events are conservatively reported under the ablation catheter.

Manufacturer Narrative

Originally, the product lot number was reported as unknown.However, during the product investigation, the lot number was able to be retrieved from the returned device.Therefore, lot 30427529m is added to this follow up report.The biosense webster, inc product analysis lab received the device for evaluation on (b)(6) 2020.Additional information was received on (b)(6) 2020 stating that no femoral aneurysm was noted.They had used a medium curve vizigo sheath for this case, as this portion of the procedure was adjunctive to an atrial fibrillation ablation.The device evaluation was completed on (b)(6) 2021.It was reported that a patient (male, 66 year old) underwent cardiac ablation procedure for idiopathic ventricular tachycardia (idvt) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and pseudoaneurysm requiring surgical intervention.It was reported by the caller that during the premature ventricular contraction (pvc) ablation procedure, the intracardiac echo (ice) catheter (soundstar) was used to confirm a pericardial effusion.The patient was stable.A pericardiocentesis was performed and 400ml of fluid were removed.At the time of the effusion, the case was close to being completed and was concluded.The patient stayed overnight for observation.The physician did not state if the catheter was the cause of the adverse event.The effusion was noted towards the end of the pvc ablation while all catheters were being used.Upon reviewing the case with the physician, she believes it was due to the location of the pvc ring in a thin walled area, it necessarily due to catheter failure.The patient went to the operation room for a surgical repair of a pseudoaneurysm.The patient¿s condition has improved.As of (b)(6) 2020, the patient was hospitalized from the procedure the day before.The device was visually inspected, and no physical damage was found.A deflection test was performed, and the curve deflected correctly, then an electrical test was performed and no issue was found.A screening test was performed, and it passed, no issues were observed.Additionally, the device was tested for generator stockert compatibility and it passed; the temperature was displayed properly on the generator.After that, an irrigation test was performed, and the test passed, finally a patency test was performed and it passed.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint was found during the review.The device passed all specifications.The physician did not state if the catheter was the cause of the adverse event, the root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 11051774
• MDR Text Key: 223165063
• Report Number: 2029046-2020-01957
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30427529M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM; NON-BWI BAYLIS NRG TRANSEPTAL NEEDLE; UNK_SOUNDSTAR; CARTO 3 SYSTEM; NON-BWI BAYLIS NRG TRANSEPTAL NEEDLE; UNK_SOUNDSTAR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR