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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pericardial Effusion (3271)

Event Date 08/10/2021

Event Type  Injury  

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient in her late 80¿s underwent an atrial tachycardia (at)/ atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered pericardial effusion (pe) requiring prolonged hospitalization and administration of heparin.It was reported that transseptal access was done with a cardiaguidewire and a baylis needle.The left atrium was mapped when anesthesiology reported that the patient's blood pressure had dropped.No radiofrequency (rf) was delivered prior to the identification of a pericardial effusion.The pericardial perfusion was confirmed using intracardiac echocardiography (ice).The procedure was aborted, and the effusion was being monitored.No ablation had been performed.No surgical intervention was required.The patient was given a reversal agent (heparin) and the patient stayed in the lab approximately 30 minutes to monitor her condition and size of effusion.Post echo was done and effusion resolved.The patient was admitted for overnight monitoring.The physician typically has the same day discharge so extended hospitalization was required in this case.The patient was stable and was reported to have fully recovered (no residual effects).The physician¿s opinion regarding the cause of this adverse event is that this is patient condition related, as well as device malfunction related.The physician stated that the patient¿s anatomy may have contributed to the adverse event.He stated that he was not able to access the left atrium mid septum.He also stated that the needle after access may have punctured the left atrial posterior floor.Prior to noting the pe, ablation was not performed.There was no evidence of a steam pop.The event occurred post transeptal, after mapping with a pentaray catheter.The stsf was in the left atrium while maintaining a force of 5-25 grams.

Manufacturer Narrative

Initially, it was reported that a product with catalog d134804, lot 30572023l was involved in this complaint.However, a different product was received at biosense webster product analysis lab.After some follow up, it was confirmed on 21-oct-2021 that the product that was received is the correct product for this complaint.Therefore, d4.Lot, d4.Expiration date and h 4.Device manufacture date were updated on this report.The device evaluation was completed on 4-nov-2021.It was reported that a female patient in her late 80¿s underwent an atrial tachycardia (at)/ atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and suffered pericardial effusion (pe) requiring prolonged hospitalization and administration of heparin.It was reported that transseptal access was done with a cardiaguidewire and a baylis needle.The left atrium was mapped when anesthesiology reported that the patient's blood pressure had dropped.No radiofrequency (rf) was delivered prior to the identification of a pericardial effusion.The pericardial perfusion was confirmed using intracardiac echocardiography (ice).The procedure was aborted, and the effusion was being monitored.No ablation had been performed.No surgical intervention was required.The patient was given a reversal agent (heparin) and the patient stayed in the lab approximately 30 minutes to monitor her condition and size of effusion.Post echo was done, and effusion resolved.The patient was admitted for overnight monitoring.The physician typically has the same day discharge so extended hospitalization was required in this case.The patient was stable and was reported to have fully recovered (no residual effects).Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned sample revealed that the rocker lever was detached from the device, however welding residues were found on the handle and this show that the rocker lever was attached on the thermocool® smart touch® sf bi-directional navigation catheter.The magnetic, temperature, and force features were tested, and no issues were observed.In addition, the product was irrigated correctly.No malfunctions were observed during the product analysis.The deflection test was performed correctly.A manufacturing record evaluation was performed for the finished device 30572029l number, and no internal action related to the complaint was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.Also, for the rocker lever condition, the ifu contain the following instructions: using aseptic technique, remove the catheter from the package and place it in a sterile work area.Inspect the catheter carefully for electrode integrity and overall condition.And during the procedure the following warning; always place the rocker lever in the neutral position to straighten the catheter tip before insertion or withdrawal of the catheter.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.At this time is not possible to determine the root cause of the rocker lever detachment condition, however, based on the information provided, the condition reported have origin in someplace external to the manufacturing environment.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event.Investigation findings: fracture problem (c070603) / investigation conclusions: cause not established (d15) / component code: actuator (g04002) were selected as related to the rocker lever that was detached from the device.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12435998
• MDR Text Key: 273854185
• Report Number: 2029046-2021-01497
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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: 05/31/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30572029L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BAYLIS TRANSSEPTAL NEEDLE; TRNSPTL FXD SHEATH,63CM,ML1; UNK_PENTARAY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female