MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. SMARTABLATE SYSTEM IRRIGATION PUMP (US); CARDIAC ABLATION PERCUTANEOUS CATHETER

Model 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	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no manufacturer record evaluation could be performed.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 two reports: mfr # 2029046-2020-00844 for product code unk_preface sheath.Mfr # 2029046-2020-00845 for product code unk_smartablate pump.
Event or Problem Description
It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with a preface® guiding sheath with multipurpose curve and a smartablate¿ system irrigation pump (us) and suffered air embolism.While mapping the right superior pulmonary vein (rspv) with the thermocool® smart touch¿ bi-directional navigation catheter, a possible calcification or potential air bubble was visualized using the soundstar catheter.It is unknown if medical/surgical intervention was provided.There¿s no indication that extended hospitalization was required as a result of the event.The patient was reported in stable condition.No bwi product malfunctions were reported.Physician causality opinion is unknown.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: SMARTABLATE SYSTEM IRRIGATION PUMP (US)
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10259594
• Report Number: 2029046-2020-00845
• Device Sequence Number: 2603733
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/12/2020

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: UNK_SMARTABLATE PUMP
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/10/2020
• 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