MAUDE Adverse Event Report: STERILMED, INC. SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	R10439236
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with two soundstar eco 8f diagnostic ultrasound catheter¿s and suffered a cardiac perforation and cardiac tamponade which required surgical intervention and prolonged hospitalization.The reprocessed catheter (soundstar eco 8f diagnostic ultrasound catheter) was not showing up on the s70 ultrasound machine but was showing up on the carto 3 system.They replaced the swift link cable but that did not resolve the issue.The catheter was replaced and that did not resolve the issue.During the procedure, a pericardial effusion was noticed.The caller reported there were no visible signs on the patient.The pericardial effusion was confirmed by eco.The caller reported that the medical intervention provided was a pericardiocentesis and it was unknown how much fluid was removed.The patient was reported to be in stable condition.Additional information was received.The ablation catheter was never used.The physician was performing a transseptal puncture and noted a possible flicker and possible screen freeze on the ice imaging.The physician performed the transseptal puncture with a needle.Sales rep reports he is 99% sure it was heartspan needle through st.Jude sl sheath.The aorta was punctured and led to the effusion.Drainage was performed but the patient required surgical intervention followed by prolonged hospitalization.Patient outcome currently is stable but still hospitalized.The sales rep did a thorough review of the event with an ultrasound rep and determined that the reprocessed soundstar catheters are suspected to be "bad" and related to the "flicker" or "possible image freeze" as it is difficult to tell during live imaging.The representative confirms the smarttouch surround flow catheter was present but was in packaging on the table.The adverse event was assessed as mdr reportable under both the reprocessed catheter¿s (soundstar eco 8f diagnostic ultrasound catheter).
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Sterilmed manufacturer's reference number pc-001302448 has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation was completed on 03-apr-2023.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 and no internal actions 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.Manufacturer's reference number: (b)(4).

• Brand Name: SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16548093
• Report Number: 2134070-2023-00008
• Device Sequence Number: 20399364
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: 10888551045094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 11/08/2023
• Device Model Number: R10439236
• Device Catalogue Number: R10439236
• Device Lot Number: 2180315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BWI SMARTTOUCH SURROUND FLOW CATHETER; CARTO 3 SYSTEM; IMAGING CATHETER; NON STERILMED-HEARTSPAN NEEDLE; NON STERILMED-S70 ULTRASOUND MACHINE; NON STERILMED-ST.JUDE SL SHEATH; SOUNDSTAR ECO CABLE ASSY 10 FT; UNKNOWN BRAND CABLE
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown