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

Model Number M490008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 06/12/2020

Event Type  Injury  

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 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)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10259594
• MDR Text Key: 199265835
• Report Number: 2029046-2020-00845
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371093
• UDI-Public: 04260166371093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M490008
• Device Catalogue Number: UNK_SMARTABLATE PUMP
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening