MAUDE Adverse Event Report: Centurion Medical Products, LP CENTURION; INTRO-FLEX INTRODUCER 8.5F

Catalog Number	I300F85
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "doctor is facing issues in loading swan-ganz in contamination shield, they observed contamination shield has kink due to which swan-ganz catheter is not passing through.".
Additional Manufacturer Narrative
The facility reported that they observed the contamination shield has a kink due to which swan-ganz catheter is not passing through; this occurred at the beginning of a cabg procedure, there was a delay in procedure time, the procedure was completed, and there was no impact to the patient.No sample or photo was received for the investigation; finished good production records were reviewed and did not find any related nonconformances, and finished good pack build review of the bom found no issues.Based on the complaint details, sample evaluation, and the investigation, the issue is not confirmed.The root cause for the reported issue is unable to be identified, and the supplier quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CENTURION
• Common Device Name: INTRO-FLEX INTRODUCER 8.5F
• Manufacturer (Section D): Centurion Medical Products, LP; 301 catrell drive; howell MI 48843 -170
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50937444
• Report Number: 1824619-2026-00138
• Device Sequence Number: 18541258
• Product Code: OFD
• UDI-Device Identifier: 10653160248538
• UDI-Public: 10653160248538
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: I300F85
• Device Lot Number: 2024040290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown