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

Model Number	RD087031
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 60¿s female with history of persistent atrial fibrillation.Procedure: ablation cryo-ensite.Steerable catheter gets re-sterilized outside the hospital at a company, sterilmed.When the re-sterilized catheter was used, it would not steer and had a sharp angle on it.We removed it from the case the tip was broken.A brand new catheter was opened and used.No known harm to patient.Manufacturer response for reprocessed intravascular ultrasound catheter, na (per site reporter).Will obtain.

• Brand Name: NA
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 16609592
• Report Number: 16609592
• Device Sequence Number: 17347712
• Product Code: OWQ
• UDI-Device Identifier: 10888551045216
• UDI-Public: (01)10888551045216(17)231213(10)2181932
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/22/2023
• Report Date (Section F): 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RD087031
• Device Catalogue Number: RD087031
• Device Lot Number: 2181932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 98 KG
• Date Report Sent to FDA: 03/22/2023