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); Stroke/CVA (1770)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Biosense webster inc's reference number (b)(4) has two reports: manufacture report number # 2029046-2021-02267 for product code 301803m (preface® guiding sheath with multipurpose curve).Importer report number (b)(4) product code m490008 (smartablate¿ system irrigation pump (us)).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a preface® guiding sheath with multipurpose curve and a smartablate¿ system irrigation pump (us) and the patient suffered a stroke.It was reported that at the end of the premature ventricular contraction ablation, the patient suffered a stroke.The ablation had been performed in the right ventricular outflow tracts (rvot) and aortic root using a thermocool® smart touch® sf bi-directional navigation catheter.At the end, the physician noticed air entering the syringe during aspiration with the preface® guiding sheath with multipurpose curve.The patient complained of body aches.The reporter was unaware of any other patient symptoms.Further neurologic testing revealed that the patient had a stroke.The patient was conscience during and after the procedure and had been transferred to the intensive care unit (icu).Further patient status was unknown.The physician was unsure how or when the air embolus and stroke occurred, possibly from one of the pressurized saline bags used during ablation.The physician did not indicate that they believed bwi products contributed to the patient event.
Additional Manufacturer Narrative
On 4-feb-2022, additional information was received indicating the adverse event was discovered post use of biosense webster products.The outcome of the adverse event was reported as fully recovered.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Importer'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: 13114712
• Report Number: 2029046-2021-50014
• Device Sequence Number: 4717648
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2022
• Report Date (Section F): 12/10/2021

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 Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2022
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: PREF.GUIDING SHEATH W/MULT.CRV; THMCL SMTCH SF BID, TC, D-F
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown