MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV; CARDIAC ABLATION CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Hemorrhage/Bleeding (1888); Sepsis (2067); Respiratory Tract Infection (2420); Pseudoaneurysm (2605); Renal Impairment (4499)

Event Date 01/16/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

"this complaint is from a literature source.The following literature cite has been reviewed: darma a, bertagnolli l, dinov b, shamloo as, torri f, efimova e, dagres n, husser-bollmann d, bollmann a, hindricks g, arya a.Role of assist device implantation and heart transplantation in the long-term outcome of patients with structural heart disease after catheter ablation of ventricular tachycardia.Herzschrittmacherther elektrophysiol.2021 jul 16.English.Doi: 10.1007/s00399-021-00787-y.Epub ahead of print.Pmid: 34269843.Objective: this matched case-control study sought to assess the difference in survival after left ventricular assist device (lvad) implantation and/or heart transplantation (htx) in shd patients undergoing vt ablation.Methods/study data: a total of 21 patients receiving an lvad, htx or both who underwent catheter ablation of vt between 2012 and 2015 at the heart centre of leipzig were included.Fluoroscopy-guided transseptal puncture was used to access the left atrium (la) and a long sheath (agilis abbott medical) was introduced into the la.When an epicardial approach was needed, an epicardial puncture and a long sheath (agilis-epi abbott medical) were used.Electroanatomic mapping was performed using the carto-3 system (bwi) or the ensite-velocity navigation system (st.Jude medical).Radiofrequency alternating current was delivered in a unipolar mode between the irrigated tip electrode of the ablation catheter (f type, irrigated tip, thermocool, (bwi); therapy cool flex ablation catheter, (st jude medical) and an external backplate electrode.Follow-up included a review of records of all hospital and outpatient clinic visits and discussions with referring cardiologists and primary care physicians from the first ablation to the time of death/last visit or contact.If patients reported vt recurrence, additional examinations were provided.When indicated, the patients were treated with redo procedures or additional antiarrhythmic drugs during follow-up.If the clinical status of the patients deteriorated, they were evaluated and listed for lvad/htx, according to the indications suggested by the existing guidelines.The patients with implanted lvad or after htx were routinely examined every 4¿6 months in the authors¿ outpatient clinic.If the patient had an intracardiac defibrillator/pacemaker, routine device interrogation was also performed to detect asymptomatic arrhythmias.The authors concluded that after performing case control matching in a contemporary cohort of patients with structural heart disease undergoing vt ablation, the patients after implantation of lvad showed similar survival to the control group.Cause of death between the two groups differed, with device-associated complication and heart failure being the main cause of death in each group, respectively.The patients after heart transplantation had an excellent long-term outcome.Complications: the incidence of major complications after ablation was similar in the two groups).Five complications occurred in patients from the lvad/htx group; these consisted of one cardiac resuscitation during the procedure due to coronary air embolism, one gastrointestinal hemorrhage, one vascular access complication (pseudoaneurysm) needing surgical correction and one patient needing dialysis after the procedure.The three complications in the control group consisted of two patients with nosocomial pneumonia progressing to sepsis and one vascular access complication needing stenting.Deaths: in this matched cohort, 16 deaths occurred in the first 44 months after vt ablation: seven in the control group and nine in the lvad/htx group.All deaths in the lvad/htx group occurred in lvad recipients, while all patients receiving htx survived follow-up.Three patients in the control group died of end-stage global heart failure, one after refractory vts, two of sepsis and one death remained unclear.In the lvad group, two patients died of right heart failure (one of them resulting from refractory vts), two suffered lethal endocranial bleeding or stroke postoperatively, two died due to sepsis, one did not survive a postoperative acute abdomen, one died from an lvad dysfunction and one death remained unclear.Evidently, the cause of death between the groups is different, with end-stage heart failure being the main lethal factor in the control group, whereas in the lvad group right heart failure and device-associated complications (bleeding, infection, etc.) were the main causes of death.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool f type irrigated-tip ablation catheter.Other biosense webster devices that were also used in this study: carto-3 system (bwi).Non-biosense webster devices that were also used in this study: long sheath (agilis abbott medical).Therapy cool flex ablation catheter, (st jude medical).Ensite-velocity navigation system (st.Jude medical).Adverse event(s) and provided interventions: complications: 5 complications in the lvad/htx group: 1 intraoperative air embolism treated with cardiac resuscitation.1 gastrointestinal hemorrhage- no treatment specified.1 pseudoaneurysm at the vascular access site- treated surgically.1 patient needed postoperative dialysis for unknown reasons (captured as acute kidney failure).3 complications in the control group: 2 reports of pneumonia progressing to sepsis- no treatment specified.1 vascular access site complication treated surgically with stenting.Deaths: 16 deaths occurred within the first 44 months after vt ablation.The authors do not specify the timing of the deaths that follow: deaths in lvad/htx group: 2 patients died from re-existing end-stage heart failure unrelated to the ablation surgery.2 deaths attributed to postoperative endocranial bleeding or stroke.2 postoperative sepsis.1 death attributed to unspecified acute abdomen (captured as injury).1 death attributed to lvad malfunction not attributed to ablation surgery.1 death for unknown reasons.Deaths in control group: 3 deaths attributed to pre-existing end-stage global heart failure.2 deaths attributed to pre-existing refractory vts not attributed to the ablation procedure.2 deaths due to sepsis.1 death for unknown reasons.The deaths attributed to lvad malfunction.Preexisting heat failure and preexisting vts will be excluded from this report as they were not associated with a bwi device or the ablation procedure.The deaths for unknown reasons will also be excluded as there is insufficient information provided to determine if the death was associated with a bwi and/or the ablation procedure.".

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: CARDIAC ABLATION 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12393744
• MDR Text Key: 274767777
• Report Number: 2029046-2021-01449
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention