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

Model Number D134702

Device Problems Image Orientation Incorrect (1305); Incorrect, Inadequate or Imprecise Result or Readings (1535); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/29/2021

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 (b)(6) year-old female patient that has eliquis prescription underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, the physician was ablating in the lateral left atrium for 54 seconds with normal force readings of 16 grams, when a steam pop occurred.The force vector immediately inverted on the carto 3 system.There was no predicating impedance rise or drop when it occurred.The physician observed nothing immediately on the intracardiac echo (ice), so they waited about a minute and began ablating on the roof area.Ice was observed again, and pericardial effusion was noted.Catheters were pulled out of the patient, heparin was reversed, and a pericardiocentesis was performed to remove over 1 liter of blood from the pericardial space.Drain was left in place, the bleeding stopped, and surgery was not required.Patient stayed for overnight observation in the intensive care unit.The patient remained in stable condition and her condition improved.The drain was removed the day after.Transthoracic echo (tte) was normal.It was also reported that earlier in the case with the same catheter, they had to keep re-zeroing stsf catheter, force reading was drifting.Other than re-zeroing the catheter multiple times, no troubleshooting was performed, catheter was not exchanged.The physician believes there was an unresolved force issue with this catheter.Physician¿s opinion regarding the cause of the event is that it was related to the biosense webster, inc.(bwi) product deficiency, specifically to the force reading.Transseptal puncture was done with a heartspan 71cm needle and preface sheath.The catheter flow was set at 15 ml/min.Pump was switching from low to high during the ablation.Correct catheter settings were selected on the generator.No error messages were reported.The force visualization feature used included graph, dashboard, vector and visitag.Tag index with 3mm tags was used as stability parameter with the visitag module.Surpoint was used as coloring option.Since the event (cardiac tamponade) is life threatening and required intervention to prevent permanent impairment of a body function, or permanent damage of a body structure, then it is to be considered serious and mdr-reportable.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.Thus, it was assessed as not mdr reportable.The force issue was assessed as not mdr-reportable.The issue with the inverted force vector was assessed as not mdr reportable.Despite the incorrect force vector visualization, the device can function as intended, because the catheter can still be displayed using fluoroscopy and the carto 3 navigation system.The potential that it could cause or contribute a death, serious injury, or other significant adverse event was remote.The risk to the patient was low.

Manufacturer Narrative

The biosense webster, inc.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).

Manufacturer Narrative

It was reported that a 71-year-old female patient that has eliquis prescription underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, the physician was ablating in the lateral left atrium for 54 seconds with normal force readings of 16 grams, when a steam pop occurred.The force vector immediately inverted on the carto 3 system.There was no predicating impedance rise or drop when it occurred.The physician observed nothing immediately on the intracardiac echo (ice), so they waited about a minute and began ablating on the roof area.Ice was observed again, and pericardial effusion was noted.Catheters were pulled out of the patient, heparin was reversed, and a pericardiocentesis was performed to remove over 1 liter of blood from the pericardial space.Drain was left in place, the bleeding stopped, and surgery was not required.Patient stayed for overnight observation in the intensive care unit.The patient remained in stable condition and her condition improved.The drain was removed the day after.Transthoracic echo (tte) was normal.It was also reported that earlier in the case with the same catheter, they had to keep re-zeroing stsf catheter, force reading was drifting.Other than re-zeroing the catheter multiple times, no troubleshooting was performed, catheter was not exchanged.The physician believes there was an unresolved force issue with this catheter.Device evaluation: the investigational analysis has been completed on 5/23/2021.Visual analysis of the returned product revealed that no damage or anomalies were observed on the 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 30487698m number, and no internal action was found during the review.As part of biosense webster¿s inc.Quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions 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 UNI-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: 11733861
• MDR Text Key: 247882253
• Report Number: 2029046-2021-00672
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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,Followup
• Report Date: 03/29/2021

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 Expiration Date: 02/04/2022
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30487698M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 04/29/2021; 05/23/2021
• Supplement Dates FDA Received: 05/05/2021; 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTSPAN 71CM TRANSSEPTAL NEEDLE; UNKNOWN PREFACE SHEATH; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR