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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no manufacture record evaluation (mre) review could be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-04016 and 2029046-2019-04022 are related to this same incident.Manufacture reference no: (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation (stsf) catheter and a carto 3 system suffered hypotension.There was an erasable programmable read only memory (eeprom) error displayed on the carto 3 system.Catheter replacement resolved the issue.In the middle of the case, char was noticed on the tip of the catheter.The catheter was cleaned, reinserted in the body, and the procedure continued.Later in the case, the catheter was pulled out of the body, and more char was noticed on the tip of the catheter.While mapping with the ablation catheter, data streaming errors (278, 268 & 258) displayed on the carto 3 system.The patient interface unit (piu) was shut down and rebooted.Troubleshooting was performed and the location pad was disconnected and reconnected.However, errors continued to display.The study was exited and reopened with no resolution.The patient interface unit (piu) and the workstation were then completely shut down.Thereafter, the workstation was booted up.A new study with a default template was opened then the piu was powered.The issue resolved.After resolving the data streaming errors, the case was canceled, as the patient was not stable enough to continue the treatment of arrhythmia.Electrocardiogram (ecg) signals and right ventricular pace was not able to be seen while the carto 3 system was down.However, the physician did have at least one ecg signal available to monitor patient¿s heart rhythm.There were no issues related to temperature or flow of the catheter.Generator was set to power control mode with a cutoff of 45 watts.The patient received and unknown anticoagulant during the procedure.The activated clotting time was 250-300 seconds, which was maintained for the bulk of the procedure.No ablations were over 60 seconds or 40 grams.Default pre-ablation high setting was used.Heparinized saline was used as irrigation fluid with default irrigation settings.Visitag parameters were set to: respiration, 2.5mm stability, 25% 5g force over time, 2mm tag size, and tag index color option.This was a 3rd repeat ischemic ventricular tachycardia (vt) ablation for that patient.Only stsf was used for mapping due to physician¿s concern of inducing vt with pentaray.About 1.5 hour into mapping in the ventricle wall, the catheters disappeared, and all the signals disappeared on the carto and the recording system.The biosense webster inc.(bwi) representative spent 23 minutes with the technical services on the phone, and eventually was advised to open a new study.The new study resolved the issue.The physician indicated 2 hours of the procedure was lost.During the troubleshooting, the patient developed vt several times and defibrillation was performed 3 times.After the 3rd shock the vitals started to drop, the heart started getting weaker and weaker and even though there were qrs complexes were visible.The blood pressure was very low (26/10-s), resulting in chest compressions being initiated.The physician decided to perform several more ablations and the case was stopped.The ablation procedure was stopped before reaching the physician¿s desired endpoint due to severe hypotension.Physician indicated the exact cause of this hypotension is unknown.Physician opinion is that the prolonged anesthesia led to drop in blood pressure.The catheter was used with default irrigation settings.Same issue happened to the same patient on january 2nd for a previous vt ablation with carto on the same system with the same piu, with a different bwi representative.They never saw these errors except for these two cases.Per the physician, extended hospital stay was required.The patient was hospitalized but may not be due to the procedure but due to the patient¿s underlying condition.The patient passed away during hospitalization as a result of ventricular tachycardia.The stsf catheter is not believed to be a contributing device to the death.The carto 3 system is believed to be the contributing device to the death and is being reported under report no: 2029046-2019-04022.

Manufacturer Narrative

During an internal review on may 28, 2020, a correction was noted to the 3500a initial report.In ¿h10.Addnl.Manf.Narrative/corrective data¿ as it originally referenced an incorrect manufacturer reference number.Originally it stated, ¿biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-04022 and 2029046-2019-04016 are related to this same incident.¿ it should have stated, ¿biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Reports 2029046-2019-04022 and 2029046-2019-04016 are related to this same incident." if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture ref no: (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; 33 technology drive; irvine CA 92618
• MDR Report Key: 9491303
• MDR Text Key: 188847162
• Report Number: 2029046-2019-04016
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Death; Hospitalization; Required Intervention