MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US); CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M490008

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Bradycardia (1751); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Investigation is in progress, once completed a supplemental will be submitted.(b)(4) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that an (b)(6) female with history of paroxysmal afib, underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ system irrigation pump (us) and the patient suffered air embolism causing bradycardia, electrocardiogram st segment elevation and requiring prolonged hospitalization.The patient suffered an air embolism.It was reported the account did not have any of the 1000cc bags of normal saline for use with the smartablate pump and a 500cc bag was used.The settings were not adjusted for the smaller bag and fluid ran out in the middle of the procedure and no warning was activated due to the settings.They noticed the bag was empty and air was suspected of getting into the patient.The patient experienced ventricular bradycardia and st elevations.Both resolved and it was decided to continue the procedure.At the end of the procedure the patient was not waking up.They are monitoring the patient and no other intervention is planned at this time.Additional information was later received indicating that medical intervention provided was ventricular pacing and medication for hemodynamic support and a computed tomography (ct) brain scan and ecg.Patient outcome from the adverse event was reported as improved.The patient required extended hospitalization to support and monitor the patient¿s condition.The sheath used during the procedure was not a bwi product.Smartablate generator was not set for the correct irrigation bag size and fast flush was able to deplete the bag without sensing bubbles or triggering a low fluid alarm.Changed to a new irrigation bag and set the smartablate appropriately.The physician¿s opinion on the cause of this adverse event is that it was procedure related.

Manufacturer Narrative

It was reported that an 81-year-old female with history of paroxysmal afib, underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ system irrigation pump (us) and the patient suffered air embolism causing bradycardia, electrocardiogram st segment elevation and requiring prolonged hospitalization.The patient suffered an air embolism.It was reported the account did not have any of the 1000cc bags of normal saline for use with the smartablate pump and a 500cc bag was used.The settings were not adjusted for the smaller bag and fluid ran out in the middle of the procedure and no warning was activated due to the settings.They noticed the bag was empty and air was suspected of getting into the patient.The patient experienced ventricular bradycardia and st elevations.Both resolved and it was decided to continue the procedure.At the end of the procedure the patient was not waking up.They are monitoring the patient and no other intervention is planned at this time.Additional information was later received indicating that medical intervention provided was ventricular pacing and medication for hemodynamic support and a computed tomography (ct) brain scan and ecg.Patient outcome from the adverse event was reported as improved.The physician¿s opinion on the cause of this adverse event is that it was procedure related.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The mre was performed for the finished device, and no internal actions related to the reported complaint was found during the review.As part of biosense webster¿s quality process all devices are manufactured, inspected, and released to approved specifications.Repair follow-up was performed as the device was not shipped for service or repair.Service was declined by the customer.As such, the reported complaint cannot be confirmed.H6.Investigation conclusion code of "appropriate term/code not available (d17)" was selected to represent "service was declined" if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed that the following concomitant products were inadvertently omitted from the 3500a initial medwatch report and have now been added: 1.Thmcl smtch sf unid, tc, d.2.Smartablate pump kit-us.3.Smartablate pump spare-us.4.Non-bwi sheath.

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 12510840
• MDR Text Key: 272722587
• Report Number: 2029046-2021-50008
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2021,11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M490008
• Device Catalogue Number: M490008
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/22/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female