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

Catalog Number	DYNJ41133D
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Altered State of Consciousness (4589)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 an "air embolism" was identified "on fluoroscopy" during a "left heart cath procedure" which caused the patient to become "unresponsive, hypotensive, and have st changes".The customer reported that there was a "crack on the end of the manifold where connecting tube connects to manifold going to catheter".The customer reported the patient required "high flow o2, narcan, and neosynephrine" due to the incident, and the patient was "doing fine" after intervention.The customer reported after the incident occurred the manifold was exchanged, and the procedure was able to be completed.No additional information is available at this time.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.
Event or Problem Description
According to the customer, on (b)(6) 2025 an "air embolism" was identified "on fluoroscopy" during a "left heart cath procedure" which caused the patient to become "unresponsive, hypotensive, and have st changes".

• Common Device Name: CARDIAC CATH PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22784897
• Report Number: 1423395-2025-00089
• Device Sequence Number: 9822952
• Product Code: OES
• UDI-Device Identifier: 10198459249662
• UDI-Public: 10198459249662
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/12/2025

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: DYNJ41133D
• Device Lot Number: 25DBR410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 117 KG