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); Device-Device Incompatibility (2919); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 10/21/2022

Event Type  Injury  

Event Description

It was reported that an unknown male patient (approximately 200 pounds) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a vascular dissection requiring prolonged hospitalization.It was reported that the catheter was not deflecting correctly when going retrograde for aortic access.The bwi company representative offered to replace the catheter and the doctor declined.The force was never zero'd.The catheter was pulled out but when he attempted to place the catheter back in there was resistance.A new catheter was used, and the issue did not resolve.An aortagram was performed and a dissection was noted.The case was then cancelled, and the patient went for a ct and was stable.The carto serial number is 11325.Physician partner wanted to know where to zero the catheter in the body or in air.Biosense hardware worked within specification.The company representative stated the doctor may of felt a steam pop.The catheter was disposed of at the end of the case.The adverse event was noticed towards the end of the case after the physician pulled out the ablation catheter from the arterial access.The premature ventricular contraction (pvc) came back, and the physician wanted to do more ablation.Upon re-inserting the catheter, the physician was unable to advance the catheter to the heart from the arterial access.The physician¿s opinion was that the catheter was ¿broken.¿ as soon as he told me this, i offered to swap out the catheter for a newer one, but he declined and kept trying to use the same ablation catheter.Another staff member who is a technician in the lab had mentioned that it was possible that he left the catheter deflected when pulling it out.The bwi company representative cannot verify if this is the case but it would make sense as to why the aortic dissection happened.The patient went for a ct scan and the bwi sales consultant heard from one of the physician¿s partners the next day that the patient was ¿stable.¿ it is unknown how the patient is doing other than that the physician¿s partner said that the patient was stable.The patient required extended hospitalization because of the adverse event.The age of the patient is unknown, but it was a middle-aged adult.Relevant history includes patient had both pvcs and vt.A smart ablate generator with serial number g4c-5214-a was used.The patient was not intubated and was under light sedation from what for approximately 4 hours.The physicians kept the patient somewhat lightly sedated so that the pvcs did not suppress.A transseptal puncture was not performed prior to the case cancellation.No cancellation happened due to the adverse event.The pvc/vt remained and can continue to pose risks to the patient¿s life and health as it was not successfully ablated.Due to the severity of the complication, the physician did not proceed.The patient required extended hospitalization due to adverse event, they were admitted to the hospital as result of this complication, it is unknown how long they have been hospitalized.Prior to noting the dissection, ablation was performed.The physician mentioned on one of the ablation lesions in the beginning of the case that he noticed a steam pop.The bwi sales consultant looked at the graph but did not see any abnormal spikes in impedance that could have been a steam pop, but the physician said that he felt a steam pop.The event happened in the post-testing phase while waiting to see if the pvc recovered.When it recovered, the physician went back in to the access site and was unable to advance the catheter.He kept trying and eventually discovered that there was another complication.The standard stsf flow settings of 8 and 15ml were used, depending on the wattage.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used were graph and dashboard.Graph was used only for impedance though.The physician refused to zero the ablation catheter.Vector was not used, the bwi sales consultant states that it is important to note that they offered to zero the catheter several times throughout the case.The physician refused to zero the catheter each time and even said on the final time that i asked him, ¿don¿t worry about that.¿ the physician did not want any visitags for this case.The steam pop occurred at the beginning of the case around the time of the first few ablations.A smart ablate generator and stsf catheter were used in the case.Generator parameters were power control mode using standard stsf settings.Pre flow rf time was at 2 seconds based on the physician¿s preferences temperature was in the 25+ degrees celsius range from what the reporter remembers.Impedance dropped during the ablation and the power was anywhere from 30-40 watts.The length of the ablation cycle when the pop was observed at the same tip position was about 20 seconds long.There was significant resistance encountered when inserting the catheter again.It would not advance to the heart and the physician complained that the catheter was broken and wasn¿t advancing.The catheter was replaced eventually after much difficulty and the doctor still could not advance the catheter into the heart.He continued to push and try to advance the catheter back in but was never able to.Deflection issue is not mdr-reportable.Force issue is not mdr-reportable.Steam pop is not mdr-reportable.Resistance with sheath 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 and mdr-reportable.

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).

Manufacturer Narrative

On 20-dec-2022, the product investigation was completed.It was reported that an unknown male patient (approximately 200 pounds) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a vascular dissection requiring prolonged hospitalization.Device evaluation details: visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested, and no issues were observed.In addition, the product was deflecting correctly.The irrigation test failed since the device has a bent tip.Additionally, the bent tip could be related to the force issue reported by the customer and the resistance issue.This bent could be related to the reinsertion with excessive force during the procedure, however, this could not be conclusively determined.A dimensional test was performed, and the outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device 30837572l number, and no internal actions related to the reported complaint condition were identified.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.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.For the force sensor 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 catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.If the force problem persists, replace the catheter cable or the catheter.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: 15821138
• MDR Text Key: 303899932
• Report Number: 2029046-2022-02856
• 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: 01/08/2023

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 Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30837572L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• 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; SOUNDSTAR ECO CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male