MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VASCULAR SOLUTION MICRO-INTRODUCER KIT 4F STIFFEN; INTRODUCER, CATHETER

Catalog Number REF 7266V

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2019

Event Type  Injury  

Event Description

Patient was having a cardiac catheterization.The right femoral vein was accessed using a micropuncture needle.The needle was taken out and micropuncture sheath broke off from the base with sheath still inside the soft tissue and vein with the wire still present.The cardiologist was unable to retrieve the sheath superficially.A general surgeon was called in to perform a right groin exploration to remove the sheath.

• Brand Name: VASCULAR SOLUTION MICRO-INTRODUCER KIT 4F STIFFEN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; MN
• MDR Report Key: 8362968
• MDR Text Key: 137197292
• Report Number: MW5084235
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• 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: 02/19/2019

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: 12/14/2021
• Device Catalogue Number: REF 7266V
• Device Lot Number: 639120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• 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: 73 YR
• Patient Weight: 129