MAUDE Adverse Event Report: CENTERLINE BIOMEDICAL INTRA-OPERATIVE POSITIONING SYSTEM (IOPS); Computer, diagnostic, programmable

Model Number	MC-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure was a fevar (pmeg) with lower extremity arterial access.Sma pre-cannulated (quickly), graft placed, sma fen cannulated all with fluoroscopy.Steerable sheath placed at fenestration with fluoroscopy then iops used to cannulate left renal artery.Repeated for right renal artery.Right renal artery dissected, recannulated with glidewire.Target vessels stented and graft fully deployed.No further reported effects on patient as the dissection was fully treated by the stent graft already being placed.

• Brand Name: INTRA-OPERATIVE POSITIONING SYSTEM (IOPS)
• Common Device Name: Computer, diagnostic, programmable
• Manufacturer (Section D): CENTERLINE BIOMEDICAL; 4535 renaissance parkway; cleveland OH 44128
• Manufacturer (Section G): CENTERLINE BIOMEDICAL; 4535 renaissance parkway; cleveland OH 44128
• Manufacturer Contact: jill godfrey ; 4535 renaissance parkway; cleveland, OH 44128
• MDR Report Key: 23495806
• Report Number: 3012154226-2025-00004
• Device Sequence Number: 8965663
• Product Code: DQK
• UDI-Device Identifier: 00843152100002
• UDI-Public: 00843152100002
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K243842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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: MC-1
• Device Catalogue Number: MC-1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown