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

Model Number	10439072
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref.# (b)(4).This event was also reported by the manufacturer under mdr #2029046-2021-00190.Reference (b)(4).
Event or Problem Description
It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure and suffered cardiac arrest requiring cardiopulmonary resuscitation (cpr) and left heart catheterization.After performing the first transseptal puncture and while mapping the left atrium (la) the patient's vital signs began to drop.The physician noticed a drop in blood pressure and heart rate.An interventional cardiologist was paged, cpr and a left heart catheterization were performed.The pentaray nav high-density mapping eco catheter and soundstar® eco diagnostic ultrasound catheter were in the body when the patient's vital signs started declining and the ablation catheter was later introduced to pace the heart.No ablation had been performed at this point.The caller stated that there were no findings (anomalies) from the left heart catheterization.The physician also used the soundstar catheter to confirm there was no effusion or perforations.The patient was stabilized, his condition improved, and the procedure was completed successfully without further complications.Physician's opinion regarding the cause of the adverse event is that it was procedure related.No bwi product malfunctions were reported.With the information available, given the adverse event occurred while mapping the la while the pentaray and soundstar catheters were inside the patient's body, this event will be conservatively coded and reported under both catheters.This report is for the soundstar.The pentaray was reported under manufacturer report number 2029046-2021-00189.

• 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: 11374380
• Report Number: 3023245-2021-00005
• Device Sequence Number: 4078537
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2021
• Report Date (Section F): 02/23/2021

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 Model Number: 10439072
• Device Catalogue Number: 10439072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 44 YR
• Date Report Sent to FDA: 02/23/2021