MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; AVA HF 9FR 11CM BUNDLE

Catalog Number	ECVC8355
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the patient's "ava hf" line was shown to be "kinked internally" when an x ray resulted.The customer reported due to the incident, the line was removed and a "picc line" was placed.The customer did not report any serious injury related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.Potential lot numbers provided by the customer: (b)(6).
Event or Problem Description
According to the customer, the patient's "ava hf" line was shown to be "kinked internally" when an x ray resulted.
Additional Manufacturer Narrative
Update to d9: sample returned update to h3: sample evaluated update to h6: type of investigation.

• Common Device Name: AVA HF 9FR 11CM BUNDLE
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico; s. de r.l. de c.v; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21055328
• Report Number: 3004519921-2025-00001
• Device Sequence Number: 8067629
• Product Code: LRO
• UDI-Device Identifier: 00653160378917
• UDI-Public: 00653160378917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/11/2025

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: ECVC8355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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