MAUDE Adverse Event Report: TRI-STATE DE MEXICO, S. DE R.L. DE C.V; VANTEX 8.5F 16CM 4L CVC BUNDLE PLUS

Catalog Number	CMPV85164LBPA
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 7/23, "the physician could not get cvc guidewire to thread.Cvc line insertion was unsuccessful prior to patient coding and expiring.Patient had additional peripheral lines for medication administration.The patient expired after coding.The device was not the cause of the code/expiration of the patient, the patient was critically ill before the provider attempted to place the vantex 8.5f 16cm 4l cvc bundle plus".A sample is not available for evaluation.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 on 7/23, "the physician could not get cvc guidewire to thread.Cvc line insertion was unsuccessful prior to patient coding and expiring.Patient had additional peripheral lines for medication administration.".

• Common Device Name: VANTEX 8.5F 16CM 4L CVC BUNDLE PLUS
• Manufacturer (Section D): TRI-STATE DE MEXICO, S. DE R.L. DE C.V; calzada presidente venustiano; desarollo industrial colorado; mexicali baja california,, 21397 ; MX 21397
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20032438
• Report Number: 3004519921-2024-00034
• Device Sequence Number: 16902938
• Product Code: LRO
• UDI-Device Identifier: 10653160374305
• UDI-Public: 10653160374305
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/21/2024

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?: Yes
• Device Catalogue Number: CMPV85164LBPA
• Device Lot Number: 2024052290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/22/2024
• 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: Unknown