MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE PUMP KIT-US; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	M490008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-00446 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2023-00447 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).(3) uf/importer report number # 2029046-2023-50006 for product code m490008 (smartablate¿ system irrigation pump (us)).
Event or Problem Description
It was reported by the clinical account specialist that during an ablation procedure they received a bubble error alert triggered by the smartablate pump.They went to troubleshoot the issue and noticed "the bag had run dry" and so they "hung a new bag".Upon trying to flush the new bag they left the wrong line open and when they tried to flush through they flushed through the line still connected inside the patient causing an embolism.The injury was confirmed via ekg monitoring and the stsf catheter showed "st elevation" through the coolflow.There was no medical intervention directly provided however the physician observed the patient until the embolism resolved and the procedure continued.The patient is now stable.The stsf catheter is available for return and the caller was advised to expect a return kit.
Additional Manufacturer Narrative
Biosense webster manufacturer's reference number (b)(4) has three reports: (1) mfr # 2029046-2023-00446 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) mfr # 2029046-2023-00447 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium) (3) uf/importer report number # 2029046-2023-50006for product code m490008 (smartablate¿ system irrigation pump (us)) during an internal review on 21-apr-2023, it was noted that the event description on the initial 3500a report # (b)(4) is missing some information.The complete event description is as follows: it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with the following devices: thermocool® smart touch® sf bi-directional navigation catheter (stsf), smartablate¿ system irrigation pump (us), and carto vizigo¿ 8.5f bi-directional guiding sheath - medium.The patient suffered an air embolism and electrocardiogram st segment elevation.It was reported that during an ablation procedure they received a bubble error alert triggered by the smartablate pump.They went to troubleshoot the issue and noticed "the bag had run dry" and so they "hung a new bag".Upon trying to flush the new bag, they left the wrong line open and when they tried to flush through, they flushed through the line still connected inside the patient causing an embolism.The injury was confirmed via ekg monitoring and the stsf catheter showed "st elevation" through the cool flow.There was no medical intervention directly provided however the physician observed the patient until the embolism resolved, and the procedure continued.The patient was stable at the time of the call.The stsf catheter is available for return.The stsf catheter was being used with a vizigo sheath, product code d138502 (lot number unknown).Pump used was a stockert gmbh smartablate system irrigation pump (sn (b)(6) ).Service was not needed.The adverse event was discovered during use of biosense webster products.The physician confirmed that the event occurred due to him having the wrong flush line open for re-flushing/priming the stsf smart ablate tubing, and air embolus traveling to patient instead of being flushed out of the line.The patient fully recovered/no residual effects.The patient did not require extended hospitalization because of the adverse event.The patient has a history of atrial fibrillation.Generator used was a stockert gmbh smartablate system rf generator (sn (b)(6) ).

• Brand Name: SMARTABLATE PUMP KIT-US
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 31; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 16474203
• Report Number: 2029046-2023-50006
• Device Sequence Number: 20703484
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023
• Report Date (Section F): 02/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: M490008
• Device Catalogue Number: M490008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8.5F SHEATH WITH CURVE VIZ MDC; SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF BID, TC, D-F
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 119 KG