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 Problems Cardiac Arrest (1762); No Code Available (3191)

Event Date 08/27/2020

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.The patient code "no code available" is being used to represent the surgical intervention.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 with history of renal failure underwent cardiac ablation procedure for atrial flutter right (r-afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac arrest requiring cardiopulmonary resuscitation and surgical intervention.It was reported that after the first thermocool® smart touch® sf bi-directional navigation catheter was inserted and used for mapping (not ablation) the carto 3 system was displaying a force sensor error 106 when the catheter was plugged into the patient interface unit.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The carto 3 system is operating per specs and is not responsible for the product issue.The procedure was continued.After ablating and while pacing the patient developed asystole with no blood pressure.Cpr was started.The anesthesiologist was able to stabilize the patient's blood pressure with epinephrine.The ultrasound showed no pericardial effusion.The hemoglobin blood test showed no internal bleeding.The patient had an internal dual-chamber pacemaker.The patient was then prepped for an impella heart pump device.The patient was stable in the cardiac intensive care unit.The physician does not believe that the ablation is the root cause of the adverse event.The patient has numerous other comorbidities, including renal failure and heart disease.The physician's opinion is that the cause of the event was the patient's condition.The patient had a left ventricle assist device (lvad) implanted and their condition has improved.The pacing leads were connected to the carto® 3 patient interface unit primary pacing port and no pacing and ablating at the same time was allowed.The stimulator was ep -4 (st jude/abbott).The pacing was planned.No inadvertent pacing was being delivered.There were two catheters involved at the time of the procedure.The first catheter was not used for ablation due to the force sensor error.The second catheter is the suspected device for the patient event.Since the cardiac arrest may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.The force sensor error is not reportable.The warning functioned as intended.

Manufacturer Narrative

On 10/1/2020, the product investigation was completed.It was reported that a patient with history of renal failure underwent cardiac ablation procedure for atrial flutter right (r-afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac arrest requiring cardiopulmonary resuscitation and surgical intervention.It was reported that after the first thermocool® smart touch® sf bi-directional navigation catheter was inserted and used for mapping (not ablation) the carto 3 system was displaying a force sensor error 106 when the catheter was plugged into the patient interface unit.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The carto 3 system is operating per specs and is not responsible for the product issue.The procedure was continued.After ablating and while pacing the patient developed asystole with no blood pressure.Cpr was started.The anesthesiologist was able to stabilize the patient's blood pressure with epinephrine.The ultrasound showed no pericardial effusion.The hemoglobin blood test showed no internal bleeding.The patient had an internal dual-chamber pacemaker.The patient was then prepped for an impella heart pump device.The patient was stable in the cardiac intensive care unit.The physician does not believe that the ablation is the root cause of the adverse event.The patient has numerous other comorbidities, including renal failure and heart disease.The physician's opinion is that the cause of the event was the patient's condition.The patient had a left ventricle assist device (lvad) implanted and their condition has improved device evaluation details: the device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.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.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: 10577096
• MDR Text Key: 208794066
• Report Number: 2029046-2020-01310
• 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
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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 Expiration Date: 04/02/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30373811M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; PENTARAY NAV; ST JUDE / ABBOTT ¿ EP 4 PACING SIMULATOR
• Patient Outcome(s): Life Threatening; Required Intervention