MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10439072
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device g4053275 number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation with a navistar® rmt thermocool® electrophysiology catheter and soundstar® eco diagnostic ultrasound catheter and suffered cardiac tamponade requiring pericardiocentesis.At the end of the procedure, the anesthesiologist reported a patient blood pressure drop which was unresponsive to their treatment.An echocardiogram with the intracardiac echo catheter revealed a 2-3cm effusion around the right ventricle (rv).A pericardiocentesis was performed removing 650 ml of blood from around the heart, it was returned to the patient simultaneously.Prolonged hospitalization was required.Patient had fully recovered from the event.Since the navistar® rmt thermocool® electrophysiology catheter was used for mapping and ablating, the physician thought it unlikely for this catheter to have caused the perforation and subsequent effusion.The physician believed the soundstar® eco diagnostic ultrasound catheter perforated the rv apex contributing to the event.No biosense webster, inc.Product malfunctions were required.Transseptal puncture was done with a baylis needle, 98 cm large curve.There was no evidence of steam pop during the ablation.The navistar® rmt thermocool® electrophysiology catheter irrigation was set to 15-30ml/min.No error messages were reported.Graph, dashboard, vector and visitag were used as force visualization features.The parameters for stability used with the visitag module was 2.5 mm for 3 seconds.Impedance was used as coloring option.This complaint was reviewed and it was assessed that this event is to be conservatively reported under both the navistar® rmt thermocool® electrophysiology catheter and soundstar® eco diagnostic ultrasound catheter.The physician attributed the causality of the event to the soundstar® eco diagnostic ultrasound catheter; however, this does not eliminate the contribution risk of the navistar® rmt thermocool® electrophysiology catheter.

• Brand Name: SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11339709
• Report Number: 2029046-2021-00187
• Device Sequence Number: 16822610
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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 Expiration Date: 10/19/2021
• Device Model Number: 10439072
• Device Catalogue Number: 10439072
• Device Lot Number: G4053275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/17/2021
• 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: Hospitalization; Life Threatening; Required Intervention