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

Model Number	7246V
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submission of this report does not represent a conclusion or admission by vascular solutions, inc.That the content of the report is complete or accurate, that the device failed or malfunctioned in any manner, or that the device caused or contributed to a death.
Event or Problem Description
A vsi micro-introducer kit was used in a patient procedure.Patient was undergoing a peripheral angiogram of the right lower extremity.The physician obtained left femoral access with a micro puncture set with ultrasound guidance.Upon retrieval of the micro puncture set the head of the sheath broke.The physician attempted to remove the remains of the sheath from the artery, but the shaft of the sheath also broke in half leaving the other half in the femoral artery.Interventional radiology was called to assist per the physician's orders.The physicians attempted to retrieve remains of sheath from left femoral artery but were unsuccessful.The patient remained in stable condition with no complaints.The physician ordered a ct scan after the procedure.Upon reviewing the ct results, the patient was taken to csu for recovery.

• Brand Name: VSI MICRO-INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 5932319
• Report Number: 2134812-2016-00060
• Device Sequence Number: 18977015
• Product Code: DYB
• UDI-Device Identifier: M2067246V0
• UDI-Public: +M2067246V0/$$31811095886985
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/12/2016

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: 11/09/2018
• Device Model Number: 7246V
• Device Lot Number: 588698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 11/23/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization