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

Catalog Number UNK_SMARTABLATE PUMP

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

Patient Problem Air Embolism (1697)

Event Date 05/30/2019

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 failure analysis can be conducted and no determination of possible contributing factors could be made.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 device history record (dhr) review could be performed.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Report 2029046-2019-03297 is related to this same incident.Manufacture reference no: (b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure with a unknown smartablate¿ system irrigation pump and suffered atrioventricular (av) heart block.After approaching the left atrium (la), heart block (av) suddenly occurred, and the st segment was elevated.Coronary artery imaging was taken, and it was noticed that the artery was clogged by air.The remainder of the procedure was aborted, and the air was collected.The patient¿s consciousness was unstable during the case, but when leaving the room, the patient¿s pulse and consciousness were stable.Patient¿s outcome was improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.The physician commented that there was a high possibility that the air has entered when inserting the sheath into la.The information of the irrigation pump used is unknown.Therefore, a generic code for unknown smartablate¿ system irrigation pump, in order to address the air embolism under this product.

Manufacturer Narrative

It was reported that a male patient underwent an ablation procedure with a unknown smartablate¿ system irrigation pump and suffered atrioventricular (av) heart block.The investigational analysis completed 12/3/2019.Repair follow-up was performed and device was not shipped for service.Service was declined.Complaint cannot be confirmed.Device information was unknown.Therefore the manufacturing record evaluation cannot be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

• Brand Name: SMARTABLATE¿ SYSTEM IRRIGATION PUMP
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8736396
• MDR Text Key: 149253175
• Report Number: 2029046-2019-03298
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

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 Catalogue Number: UNK_SMARTABLATE PUMP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASSO NAV 2515,22P SPLITHANDLE; MOBICATH SMC GUIDING SHEATH; SOUNDSTAR 3D 10F-90; THMCL SMTCH SF BID, TC, D-F; LASSO NAV 2515,22P SPLITHANDLE; MOBICATH SMC GUIDING SHEATH; SOUNDSTAR 3D 10F-90; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Required Intervention