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

Model Number D134702

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

Patient Problem Perforation of Vessels (2135)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

The bwi 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.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.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 underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a vessel perforation.It was reported that the patient suffered perforation of the ivc with the mapping catheter.After fam (fast anatomical mapping) mapping in the right atrium the physician was maneuvering the stsf catheter, retracted and re-advanced in the ivc (inferior vena cava), when the perforation occurred.A high force value was displayed on the carto 3 system and the company representative notified the physician at that time.The physician confirmed on intracardiac echo that the catheter had perforated the ivc.The physician immediately ordered anesthesia to administer protamine to reverse heparin effect, multiple act's (activated clotting time) were drawn.Once the patient's act was below 170 the catheter was entirely removed from the patient, and for thirty minutes post-catheter removal the patient was monitored and stable in the ep lab.No further intervention was necessary.They remained stable and they were transferred to the pacu for overnight monitoring.The ablation procedure was cancelled.An stsf, f-curve catheter was in use: d134702 / 30960668l.The physician did not indicate that they believed bwi products were responsible for the patient event.No transseptal puncture was performed.Ablation was not performed.Physician was building an ra fam / ivc matrix.No mapping or ablation was performed.Irrigated catheter was used in the event, flow setting was low flow setting ¿ 2ml/min.Visitag module was used, parameters for stability used was (range; time; fot; tag size) was 3, 3, 25, 3.No additional filter used with the visitag.The adverse event occurred on (b)(6)2023.It was discovered during use of stsf ablation catheter when making ivc matrix / ra fam.The physician immediately ordered anesthesia to administer protamine to reverse heparin effect, multiple act's (activated clotting time) were drawn.Once the patient's act was below 170 the catheter was entirely removed from the patient, and for thirty minutes post-catheter removal the patient was monitored and stable in the ep lab.No further intervention was necessary.They remained stable and they were transferred to the pacu for overnight monitoring.The patient was required to stay overnight for monitoring.Generator information was-g4c-4111-a.Thermocool® smarttouch® sf catheter was used to build matrix ¿ ra fam.No ablation performed.Visitag module was used, parameters for stability used (range; time) was 3,3,25,3.The patient was in the room at the time of the cancellation.Patient was under general anesthesia, duration unknown.No serious injury or death to the patient.Spoke with the physician the next day and the patient was completely stable.No active bleeding.The physician stated that his ablation catheter perfed through the inner layer of the ivc ¿ not all the way through the ivc (discovered on ct scan).The patient was required to stay overnight for monitoring.Force issue is not mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

Manufacturer Narrative

On 29-may-2023, the product investigation was completed.It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a vessel perforation.It was reported that the patient suffered perforation of the ivc with the mapping catheter.After fam (fast anatomical mapping) mapping in the right atrium the physician was maneuvering the stsf catheter, retracted and re-advanced in the ivc (inferior vena cava), when the perforation occurred.A high force value was displayed on the carto 3 system and the company representative notified the physician at that time.The physician confirmed on intracardiac echo that the catheter had perforated the ivc.The physician immediately ordered anesthesia to administer protamine to reverse heparin effect, multiple act's (activated clotting time) were drawn.Once the patient's act was below 170 the catheter was entirely removed from the patient, and for thirty minutes post-catheter removal the patient was monitored and stable in the ep lab.No further intervention was necessary.They remained stable and they were transferred to the pacu for overnight monitoring.The ablation procedure was cancelled.Device evaluation details: 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 the device was recognized correctly; however, hi force appeared due to an internal printed circuit board (pcb) issue.A manufacturing record evaluation was performed for the finished device number lot 30960668l and no internal actions related to the complaint were found during the review.The force issue reported by the customer was confirmed however, the root cause of the adverse event remains unknown.In addition, the physician did not indicate that they believed bwi products were responsible for the patient event.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.In relation to the force issue, the instructions for use (ifu) contain the following recommendations: to ensure accurate force readings, verify that the force reading is near zero when the device is not in contact with tissue.If the force reading is not near zero when the device is not in contact with tissue, perform zeroing.If the force problem persists, replace the device cable or the device.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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; 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: 16986611
• MDR Text Key: 315790184
• Report Number: 2029046-2023-01125
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30960668L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention