MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; 6F,TB BONDED, INTROFLEX INTRODUCER

Catalog Number	ECVC6305A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on 3/19 after a tvp placement, the proximal end of the contamination shield was not locking into place.The issue occurred after the procedure when the tvp wire migrated.The patient arrested but then stabilized.The patient completely lost pacing capability and arrested.The patient lost capture and was completely dependent on the pace maker.The patient survived.The procedure was completed, but the contamination shield failed to keep the pacing wire locked following procedure.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, 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 facility, on 3/19 after a tvp placement, the proximal end of the contamination shield was not locking into place.The issue occurred after the procedure when the tvp wire migrated.The patient arrested but then stabilized.

• Common Device Name: 6F,TB BONDED, INTROFLEX INTRODUCER
• 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: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21858718
• Report Number: 3004519921-2025-00008
• Device Sequence Number: 4721880
• Product Code: LRO
• UDI-Device Identifier: 10653160381037
• UDI-Public: 10653160381037
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/17/2025

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
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: ECVC6305A
• Device Lot Number: 2024110790
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female