MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ SYSTEM IRRIGATION PUMP; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	M490008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/24/2018
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.Concomitant products: pronto extraction catheter (model# unknown, lot# unknown); stockert generator (model# unknown, lot# st2355); thermocool® smart touch¿ electrophysiology catheter (model# d-1336-02-s, lot# 30046697m).Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for paroxysmal atrial fibrillation (afib) with a smartablate¿ system irrigation pump and suffered air embolism requiring air removal.During the procedure, right coronary air embolism was discovered as the physician noticed an st segment elevation.The air was removed from the right coronary artery by a pronto extraction catheter.Patient was reported to be in stable condition after air removal.Extended hospitalization was required for neurological and cardiac monitoring.Patient¿s outcome was improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.
Additional Manufacturer Narrative
It was reported that a 57-year-old male patient underwent an ablation procedure for paroxysmal atrial fibrillation (afib) with a smartablate¿ system irrigation pump and suffered air embolism requiring air removal.The investigational analysis completed 5/21/2019.Repair follow-up was performed and device was not shipped for service.Service was declined.Complaint was unable to confirm.Certificate of conformance was reviewed.It was verified that the device was manufactured in accordance with documented specification and procedures.Manufacturer ref no: (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8089929
• Report Number: 2029046-2018-02312
• Device Sequence Number: 1459212
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P990071/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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 Catalogue Number: M490008
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 06/17/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 115