MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ANGIO CATH PACK

Catalog Number	DYNJ52000D
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976); Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "we have experienced problems with nearly every single j wire in the packs.When straightening they fail to return to normal, they break easily either when outside of the body or crossing aortic valves, potentially causing serious damage and or severe complications to patients, and they also bend very easily when loading and exchanging equipment over the wire." per the facility, "there has been no patient injuries caused at this time.When the wires break it is breaking within the inner core of the wire.They will easily separate when straightening the j wire for insertion into catheters." it has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, "we have experienced problems with nearly every single j wire in the packs.When straightening they fail to return to normal, they break easily either when outside of the body or crossing aortic valves, potentially causing serious damage and or severe complications to patients, and they also bend very easily when loading and exchanging equipment over the wire." per the facility, "there has been no patient injuries caused at this time.When the wires break it is breaking within the inner core of the wire.They will easily separate when straightening the j wire for insertion into catheters.".

• Common Device Name: ANGIO CATH PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23069101
• Report Number: 1423395-2025-00128
• Device Sequence Number: 18594203
• Product Code: OES
• UDI-Device Identifier: 10198459342943
• UDI-Public: 10198459342943
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 Catalogue Number: DYNJ52000D
• Device Lot Number: 25GBN310
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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