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 Code	Air Embolism (1697)
Date of Event	01/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The mre was performed for the finished device g4cp-2017 number, and no internal action related to the reported complaint was found during the review.A repair follow-up was performed with the customer and service was declined indicating no service was needed.As such, the reported complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ system irrigation pump (us) and developed st segment elevation.During the procedure, the temperature value from the thermocool® smart touch® sf bi-directional navigation catheter (30501064m) was not displaying on the smartablate® generator and an invalid temperature error was displayed when trying to go into ablation.The cable was replaced without resolution.The catheter was replaced, and the issue resolved.The case continued.It was also reported that while using the replacement thermocool® smart touch® sf bi-directional navigation catheter (30514020m), error# 100 - eeprom data service - displayed on the carto® 3 system.The catheter was replaced, and the issue resolved.The case continued.The issue was catheter related.The carto® 3 system is operating per specs and is not responsible for the product issue.After the catheter was replaced, st segment elevation was noted on the electrocardiogram (ecg) signals.A coronary interventionist was called in and an arteriogram was performed.It was determined the coronaries were clean, so the blockage had resolved itself.A possible air embolism was suspected.The patient ecg signals were being monitored and a new sheath was set up to continue with the case.The sheaths used were not bwi products.The patient appeared to be in stable condition and the case continued.Patient had fully recovered with no residual effects.Prolonged hospitalization was not required.The physician believed there may have been some air in the ablation tubing/catheter or it occurred while exchanging the first ablation catheter for the second.Given the st segment elevation can be an indicative of air embolism and given the physician suspected and air embolism occurred, this is being conservatively coded as ¿air embolism¿.

• 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: 11807327
• Report Number: 2029046-2021-50002
• Device Sequence Number: 17120780
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/16/2021
• Report Date (Section F): 04/26/2021

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
• Distributor Facility Aware Date: 04/16/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 70 YR