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

Catalog Number D134805

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

Patient Problems ST Segment Elevation (2059); Thrombosis (2100)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30133234l number, and no internal action was found during the review.Concomitant product: smartablate pump, us catalog #: unknown, serial #: unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed thrombosis and st segment elevation.During the procedure when the ablation was being conducted in the left pulmonary vein (lpv) anterior wall, an st segment elevation was confirmed.The ablation catheter was removed, and thrombus was found attached to the tip of the catheter.Coronary angiography (cag) was performed and an embolus was noticed in the left anterior descending artery (lad).The physician inserted a percutaneous transluminal coronary angioplasty (ptca) wire and a microcatheter via the groin sheath and approached the lad; however, thrombus aspiration was not possible.The patient was transferred to the intensive care unit (icu).There¿s no information regarding extended hospitalization.Patient¿s outcome is unknown.The physician¿s commented that there was no remark about causal relationship between the product and the adverse event.Before st segment elevation occurred, the smartablate pump warned about a bubble error about 3 to 4 times, and the thermocool® smart touch® sf bi-directional navigation catheter was re-flushed.It is suspected there was a possibility of air embolus; however, since the slow flow of lad did not improve even after several minutes after cag, it is unlikely that air was the cause of the issue.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Thrombosis was considered serious and mdr-reportable.The thrombus attached to the catheter tip was also assessed as a reportable issue.The bubble error was assessed as not reportable.Since the system shows an error, the potential risk that it could cause to the patient was remote.

Manufacturer Narrative

It was reported that a 70 year old male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure when the ablation was being conducted in the left pulmonary vein (lpv) anterior wall, an st segment elevation was confirmed.The ablation catheter was removed, and thrombus was found attached to the tip of the catheter.Coronary angiography (cag) was performed and an embolus was noticed in the left anterior descending artery (lad).The physician inserted a percutaneous transluminal coronary angioplasty (ptca) wire and a microcatheter via the groin sheath and approached the lad; however, thrombus aspiration was not possible.The patient was transferred to the intensive care unit (icu).There¿s no information regarding extended hospitalization.The patient did not exhibit any neurological symptom since the procedure was completed.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested and it was working properly, the force values were observed within specifications.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test were performed and it was found within specifications, the catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on march 17, 2019.The patient was a 70-year-old male patient.The patient did not exhibit any neurological symptom since the procedure was completed.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.The generator was used in power control mode at 40 watts.The maximum ablation time per point was of 56.The irrigation flow rate was set within normal parameters for smart touch sf.The radio frequency delay time and post radio frequency time was 1 second.The ablation method used was point by point.Therefore, patient age at the time of event, age unit and sex fields have been populated.The biosense webster inc.Product analysis lab received the device for evaluation on march 21, 2019.Therefore, populated concomitant medical products.Device available for evaluation? concomitant medical products.Is device returned to manufacturer? and concomitant medical products.Date device returned to manufacturer.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.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: 8419368
• MDR Text Key: 138763598
• Report Number: 2029046-2019-02805
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30133234L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR