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

Model Number	10438577
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Air Embolism (1697); Ischemic Heart Disease (2493); Thrombosis/Thrombus (4440)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi then conducted a visual inspection and analysis of the returned device.Visual analysis of the returned sample revealed that it was in good normal condition.Then, carto 3 visualization, acuson ultrasound, and atlas transducer tests were performed, and the device passed the tests.Then, a deflection test was performed, and it was found within specifications, the catheter was deflecting correctly.A device history record (dhr) was performed, and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a 80-year-old male patient (108kg) underwent a left atrial appendage closure procedure with a soundstar® eco diagnostic ultrasound catheter and the patient suffered air embolism, thrombosis, electrocardiogram st segment elevation requiring surgical intervention.During a left atrial appendage closure procedure, a possible blood clot or air embolism was discovered to have developed in the rca (right coronary artery).Caller stated they first noticed st elevations in the ekg.To confirm a blood clot or air was in the rca, they shot contrast into the artery and found that it did have sluggish flow.They put a coronary wire down the rca and the issue resolved.Flow was restored back to the rca.The patient is stable and the procedure was continued.This was not a cardiac ablation procedure.The only bwi product in the body at the time was the soundstar catheter.The physician believes dilating the septum with the 14 fr abbot sheath may have caused the issue or putting the ice catheter across into the left atrium could have potentially added a clot or air into the left atrium.They think then the air or clot traveled out of the left atrium into the left ventricle and then shot out into the rca.Additional information received indicated the adverse event was discovered while biosense webster product was inside the body.Physician blamed the adverse event on the 14f abbott sheath.The patient outcome of the adverse event was fully recovered.No extended hospital stay and no generator used.The patient has not exhibited any neurological symptoms since the procedure was completed.No biosense webster sheath used.No servicing of pump needed.No pump was utilized in this procedure.Soundstar only product utilized.

• Brand Name: SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15568584
• Report Number: 2029046-2022-02438
• Device Sequence Number: 2984948
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: 10846835008838
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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: 06/02/2023
• Device Model Number: 10438577
• Device Catalogue Number: 10438577
• Device Lot Number: E5132865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 14F ABBOTT SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 108 KG