MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ANGIOGRAPHY SPECIALS

Catalog Number	DYNJ60655F
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, a concern involving possible cerebrovascular accident type symptoms identified post-procedure in five patients who underwent diagnostic arteriograms in cair was reported.It was reported that "there is a working hypothesis that a residue associated with the ray-tecs may be present and potentially transferring into heparinized saline bowls during procedural setup.".
Additional Manufacturer Narrative
According to the customer, a concern involving possible cerebrovascular accident type symptoms identified post-procedure in five patients who underwent diagnostic arteriograms in cair was reported.It was reported that "there is a working hypothesis that a residue associated with the ray-tecs may be present and potentially transferring into heparinized saline bowls during procedural setup." it was reported that "the clustering of similar post-procedural symptoms across patients with exposure to the same product lot is concerning and warrants immediate precautionary action and further investigation." additionally, it was reported that "procedural teams indicates that a change was made approximately three months ago to the ray-tecs included in the medline angio pack." despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: ANGIOGRAPHY SPECIALS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25058859
• Report Number: 1423395-2026-00122
• Device Sequence Number: 13086515
• Product Code: LRO
• UDI-Device Identifier: 10198459214615
• UDI-Public: 10198459214615
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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 Catalogue Number: DYNJ60655F
• Device Lot Number: 25LMG572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown