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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 07/06/2023

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 01-aug-2023.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent idvt (idiopathic ventricular tachycardia) ablation procedure that included thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced a cardiac perforation that required pericardiocentesis.After the physician completed the ablation, a pericardial effusion was noticed.The patient's blood pressure dropped after an ablation lesion was completed.They visualized the heart border not moving on fluoroscopy and that the pericardial effusion was confirmed using fluoroscopy.The medical intervention provided was a pericardiocentesis and that 300 ml of fluid was removed from the patient.The patient was reported to be in stable condition.The impedance readings were high in the area they ablated, but that they were unable to confirm the reason why the pericardial effusion occurred.There were no steam pops or impedance spikes during the procedure.Additional information was received.The adverse event was discovered immediately coming off ablation.The patients pressure dropped rapidly.Physician thinks that the catheter was wedged into the tissue.The impedance at baseline in that area was 200+ohms.He suspects that ablation there could have caused a perforation.Outcome of adverse event was improved.The patient required extended hospitalization.The patient needed monitoring after their pericardiocentesis.No transseptal puncture was performed.No ablation was performed prior to noting the pericardial effusion (note: contradicting information).The event occurred during the ablation phase.Flow setting for irrigated catheter: stsf 8ml/15ml.Correct catheter settings were selected on the generator.The pump switching from "low" to "high" flow during ablation.No error messages observed on biosense webster equipment during the procedure.No impedance spike was observed.No steam pop was felt or heard.Force visualization used: graph, dashboard, vector, visitag.Visitag module parameters for stability used: respiration adjustment max distance change 2mm minimum time 3s force over time 25% minimum force 3.Visitags were colored by custom force 2g-8g.Size:2 (physician is away lesions are larger).Color options used was force.They increased the impedance cut off value to 210ohm.User was able to stop the ablation using the "stop" button (generator or remote).It did not ablate above impendence cut off value.Generator parameters: power control mode, temperature cut off 40c, impedance cut off 210ohm spike cut off 50, power 35w.Noted temperature, impedance and power: power (maximum) 42 w , average 39w); temperature (maximum 36 c, average 27 c, minimum 24 c); impedance maximum 224ohms, average 132 ohms, minimum 116 ohms, maximum drop 77 ohms/s, average drop 22 ohms / seconds); total energy 21511j, total irrigation 344 ml.

Manufacturer Narrative

It was reported that a patient underwent idvt (idiopathic ventricular tachycardia) ablation procedure that included thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced a cardiac perforation that required pericardiocentesis.The investigation was completed on 08-aug-2023.A picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, the generator screen showed the results of the ablation and it was noted that the impedance value reached the 224ohm, this value is a high impedance value, however, it cannot determine if this condition is related to the pericardial effusion occurred during the procedure, since according to the information provided it did not ablate above the impedance cut-off value.With the information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the adverse event reported by the customer.The customer complaint was not confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video 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 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17452140
• MDR Text Key: 320335235
• Report Number: 2029046-2023-01694
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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 Catalogue Number: D134805
• Device Lot Number: 31060853L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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: UNKNOWN BRAND PUMP; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 61 KG