MAUDE Adverse Event Report: VASCULAR SOLUTIONS MICRO INTRODUCER KIT

Model Number 7273V

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2016

Event Type  Injury  

Event Description

While obtaining access to the right femoral artery during cardiac catheterization, the micropuncture introducer became disconnected from the hub.The plastic sheath remained inside the pt and could not be retrieved.Required surgical intervention for retrieval of sheath.

• Brand Name: MICRO INTRODUCER KIT
• Type of Device: MICRO INTRODUCER KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS; minneapolis MN
• MDR Report Key: 5853021
• MDR Text Key: 51456491
• Report Number: MW5063887
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2016

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 Operator: Health Professional
• Device Expiration Date: 04/02/2019
• Device Model Number: 7273V
• Device Lot Number: 593230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 97