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

Model Number D134804

Device Problems Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Apnea (1720)

Event Date 01/20/2021

Event Type  Death  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 an atrial fibrillation (afib) ablation procedure with mitral isthmus line with a thermocool® smart touch® sf bi-directional navigation catheter and suffered respiratory arrest and death.Patient came in with shortness of breath before the procedure, but they had no complications during the procedure.During the mitral isthmus line, physician chose to reduce irrigation to 2 ml/min (off-label) to complete line as he was not getting block on initial pass.The ablation was completed and successful.No biosense webster, inc.Product malfunctions occurred; no high temperature readings, no impedance spikes and no pericardial effusion was seen on echocardiography post case.When the catheter was removed from the patient, there was noted char on the catheter.As the patient was waking up from anesthesia, they noted that the patient was having respiratory difficulty and suffered bradycardia.The patient remained intubated and the issues quickly resolved.A pericardial check was again performed and no evidence for effusion.A temporary pacing wire was placed due to bradycardia episode.Patient was sent to the intensive care unit (icu) intubated.Product performed as expected.There were no reported deficiencies.While in the intensive care unit (icu), patient did not demonstrate any neurological changes per physician report.Later that evening, despite a less than desirable blood gas, the patient was extubated and immediately suffered a respiratory arrest.Patient was coded but expired.The physician believes the patient was taken off the vent too early and that the patient death was due to having too much fluid in the lungs when they removed the vent.The physician stated if they had waited until the next morning, the patient would have been fine.The char was assessed as not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.With the information available, this event is being conservatively assessed reportable under the ablation catheter ¿thermocool® smart touch® sf bi-directional navigation catheter¿.Any serious injury that results in the patient¿s death is to be considered serious and mdr-reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2021.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 3/22/2021.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with mitral isthmus line with a thermocool® smart touch® sf bi-directional navigation catheter.Patient came in with shortness of breath before the procedure, but they had no complications during the procedure.During the mitral isthmus line, physician chose to reduce irrigation to 2 ml/min (off-label) to complete line as he was not getting block on initial pass.The ablation was completed and successful.No biosense webster, inc.Product malfunctions occurred; no high temperature readings, no impedance spikes and no pericardial effusion was seen on echocardiography post case.When the catheter was removed from the patient, there was noted char on the catheter.As the patient was waking up from anesthesia, they noted that the patient was having respiratory difficulty and suffered bradycardia.The patient remained intubated and the issues quickly resolved.A pericardial check was again performed and no evidence for effusion.A temporary pacing wire was placed due to bradycardia episode.Patient was sent to the intensive care unit (icu) intubated.Product performed as expected.There were no reported deficiencies.While in the intensive care unit (icu), patient did not demonstrate any neurological changes per physician report.Later that evening, despite a less than desirable blood gas, the patient was extubated and immediately suffered a respiratory arrest.Patient was coded but expired.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.The force, magnetic and temperature features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The catheter passed all specifications.The root cause of the adverse event remains unknown since no problem was found/no problem was detected.The root cause of the char on the tip was caused by decreased flow in the cool flow pump according the reported event.The evaluation determined that char is a physical phenomenon of radio frequency.Directions for use: increase the irrigation to high flow rate starting up to 5 seconds before the onset of radio frequency energy delivery and maintaining this higher flow rate until 5 seconds after termination of the energy application.For power levels up to 30w, a high flow rate of 8ml/min should be used.For power levels between 31-45w high flow rate of 15ml/min should be used.Do not use this catheter without irrigation flow.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Conclusion code ¿cause traced to user" , result code of ¿problem due to thrombosis activation¿ and component code of ¿catheter¿ are for the char issue.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11345699
• MDR Text Key: 232509178
• Report Number: 2029046-2021-00204
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30445684M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention