MAUDE Adverse Event Report: TELEFLEX INCORPORATED VSI; INTRODUCER, CATHETER

Model Number	IPN916038
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While removing micropuncture dilator to deploy angioseal, tip of dilator broke off.Retrieved by snare.Contents bagged and delivered to nsm.

• Brand Name: VSI
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 20300335
• Report Number: 20300335
• Device Sequence Number: 8686230
• Product Code: DYB
• UDI-Device Identifier: 10841156107086
• UDI-Public: (01)10841156107086
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/11/2024
• Report Date (Section F): 04/11/2024

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 Model Number: IPN916038
• Device Catalogue Number: 7266V
• Device Lot Number: 73K2300364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• 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
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Date Report Sent to FDA: 04/11/2024