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

Model Number	M490008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Air Embolism (1697); Ischemic Heart Disease (2493)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number (b)(4) has two reports: manufacture report number # 2029046-2021-01417 for product code unk_preface sheath (preface® guiding sheath with multipurpose curve).Importer report number # 2029046-2021-50006 product code m490008 (smartablate¿ system irrigation pump (us)).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a preface® guiding sheath with multipurpose curve and a smartablate¿ system irrigation pump (us) and the patient suffered air embolism and st segment elevation requiring interventional cardiology intervention.It was reported that during the afib case, during use of biosense webster products, the nurse staff went to fast flush on the smartablate¿ system irrigation pump (us) and she did not notice that there was air in the bag and flushed into the patient.The patient had st elevation.They put on 100 percent oxygen and interventional cardiology was able to get the air out the right coronary.The patient was reported to be in stable condition.The physician¿s opinion on the cause of this adverse event is that it was user error.Patient outcome from the adverse event is reported to be improved.The patient did not have an extended hospitalization.
Additional Manufacturer Narrative
On (b)(6)-2021, biosense webster inc.(bwi) received additional information indicating an 8fr sl1 sheath, a carto vizigo¿ 8.5f bi-directional guiding sheath - medium and an 8fr short sheath was used during this procedure.These items have been added to the concomitant product section.As such, updated the concomitant product description from ¿unk_preface sheath¿ to ¿8.5f sheath with curve viz mdc¿ the manufacture report number # 2029046-2021-01417 is now reportable for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium) device investigation details: the device investigation for the smartablate¿ system irrigation pump (us) has been completed which included a device history record review.The device history record evaluation revealed that no internal actions related to the product were identified.A repair follow-up was performed with the customer and service for the system was declined indicating no service was needed.As such, the reported complaint cannot be confirmed.As part of biosense webster¿s quality process all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

• Brand Name: SMARTABLATE SYSTEM IRRIGATION PUMP (US)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 12393837
• Report Number: 2029046-2021-50006
• Device Sequence Number: 19702085
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/01/2021
• Report Date (Section F): 08/09/2021

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 the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/07/2021
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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; UNK_PREFACE SHEATH; UNSPECIFIED 8FR SHORT SHEATH; UNSPECIFIED 8FR SL1 SHEATH; SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF BID, TC, D-F; UNK_PREFACE SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 70 YR