MAUDE Adverse Event Report: STERILMED, INC.; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Catalog Number	BIO10438577
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation with a reprocessed soundstar® eco 10f diagnostic ultrasound catheter and the patient experienced cardiac tamponade that required surgical intervention.During the afib case, after the physician went transseptal with the soundstar, the blood pressure dropped significantly, then the physician noticed the effusion.The injury was confirmed on intracardiac echocardiogram and by performing a transesophageal echocardiogram.A pericardiocentesis was attempted but were not able to drain any fluids.The procedure was aborted, and the patient was then taken to cardiothoracic surgery.The last known status of the patient was stable.It is unknown what led to the injury.The plan was to do pulsed field ablation (pfa) with boston scientific, but no ablating was done because after transseptal, an effusion was noticed.The soundstar catheter functioned as expected, however it is unclear if the soundstar catheter was considered to be a contributing factor to the reported event.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by sterilmed inc., or its employees that the report constitutes an admission that the product, sterilmed inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed and no internal actions related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: NA
• 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: 20753846
• Report Number: 2134070-2024-00022
• Device Sequence Number: 8587108
• Product Code: OWQ
• UDI-Device Identifier: 10888551014441
• UDI-Public: (01)10888551014441(17)250701(10)2210550
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110076
• 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

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: 07/01/2025
• Device Catalogue Number: BIO10438577
• Device Lot Number: 2210550
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: CARTO 3 SYSTEM; GENERATOR (BOSTON SCIENTIFIC)
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown