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 Cardiac Tamponade (2226)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc (b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.While mapping with a pentaray catheter in the left atrium (la) they were getting a lot of ectopy in the electrocardiogram signals.The catheter was replaced with an stsf ablation catheter.While mapping the left ventricle (lv) with the stsf, the patient started to complain of having chest pains.The ultrasound confirmed the patient had pericardial effusion.A pericardiocentesis was done to remove 375cc of fluid from the pericardial space.The patient's heart rate was elevated prior to the pericardiocentesis but then returned to normal after they removed the fluid.Pericardial drain was left in place.The patient was reported in stable condition and was moved to the cardiac intensive care unit and required prolonged hospitalization.Patient had fully recovered from the event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related, physician stated the catheter was deep in the papillary muscle.Transseptal puncture was done with a brk transseptal needle.The catheter irrigation was set at 2cc/min.No bwi product malfunctions nor error messages were reported.The force visualization features used included graph, dashboard and vector.No ablation was ever applied.The reported bad/ partial ecg signals (bs or ic) are not considered to be mdr reportable since the risk to the patient is low.

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a 77-year-old male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.While mapping with a pentaray catheter in the left atrium (la) they were getting a lot of ectopy in the electrocardiogram signals.The catheter was replaced with an thermocool® smart touch® sf bi-directional navigation catheter.While mapping the left ventricle (lv) with the thermocool® smart touch® sf bi-directional navigation catheter, the patient started to complain of having chest pains.The ultrasound confirmed the patient had pericardial effusion.A pericardiocentesis was done to remove 375cc of fluid from the pericardial space.The patient's heart rate was elevated prior to the pericardiocentesis but then returned to normal after they removed the fluid.Pericardial drain was left in place.The patient was reported in stable condition and was moved to the cardiac intensive care unit and required prolonged hospitalization.Patient had fully recovered from the event.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device number, and no internal action related to the complaint was found during the review.The catheter passed all specifications.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 ref.# (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: 10974433
• MDR Text Key: 220399888
• Report Number: 2029046-2020-01905
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30433264M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK NEEDLE; CARTO 3 SYSTEM; UNK_PENTARAY; BRK NEEDLE; CARTO 3 SYSTEM; UNK_PENTARAY
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR