MAUDE Adverse Event Report: VASCULAR SOLUTIONS VSI MICRO INTRODUCER KIT

Catalog Number 7259V

Device Problems Break (1069); Knotted (1340); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/24/2015

Event Type  Injury  

Event Description

Patient with total occlusion in the sfas bilaterally.Peripheral angiogram with runoff.Physician used left femoral approach without success.Right femoral artery access.Advanced a wire through the 4 french sheath which became knotted and physician was not able to pull the knot through to retrieve it.An attempt was made to pull the wire and the 4 french sheath as one unit.Physician was able to do that but the distal end of the wire was lost in the subcutaneous tissue.Cvt surgery was consulted but patient refused surgery at the time.

• Brand Name: VSI MICRO INTRODUCER KIT
• Type of Device: INTRODUCER KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS; minneapolis MN 55369
• MDR Report Key: 4752536
• MDR Text Key: 5826653
• Report Number: MW5042509
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/30/2015

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 Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 7259V
• Device Lot Number: 574899
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 64