MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC STIFFEN INTRODUCER, CATHETER

Catalog Number 7267V

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/04/2022

Event Type  Injury  

Event Description

Teleflex stiffen micro-introducer wire being used during a cardiac catheterization became lodged in the distal abdominal aorta.During removal of the lodged wire, a 12-15cm piece of the wire broke off of the introducer and was unable to be removed.Fda safety report id # (b)(4).

• Brand Name: STIFFEN INTRODUCER, CATHETER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC
• MDR Report Key: 14111480
• MDR Text Key: 289345042
• Report Number: MW5108981
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2022

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 Catalogue Number: 7267V
• Device Lot Number: 73L2100779
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White