MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. VSI MICRO-INTRODUCER KITS; CATHETER INTRODUCER

Model Number	7273
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A vsi micro-introducer kit was used in a patient procedure.The hub broke off from the plastic introducer and had no way of retrieving it.The physician called a vascular surgeon to take the patient to the or to have it removed.

• Brand Name: VSI MICRO-INTRODUCER KITS
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 5888582
• Report Number: 2134812-2016-00056
• Device Sequence Number: 10894528
• Product Code: DYB
• UDI-Device Identifier: M2067273V1
• UDI-Public: +M2067273V1$$3190402593230
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2016

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
• Operator of Device: Physician
• Device Expiration Date: 04/02/2019
• Device Model Number: 7273
• Device Lot Number: 593230
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2016
• Supplement Report FDA Received Date: 11/23/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention