MAUDE Adverse Event Report: TERUMO / TERUMO MEDICAL CORP. TERUMO GLIDESHEATH NITENOL; INTRODUCER, CATHETER

Model Number 15-1050

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2021

Event Type  Injury  

Event Description

The tip of the terumo 5fr glidesheath nitenol wire that was used to get access in the right basilic vein was fractured and remained in the subcutaneous tissue.

• Brand Name: TERUMO GLIDESHEATH NITENOL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO / TERUMO MEDICAL CORP.
• MDR Report Key: 11669701
• MDR Text Key: 245853126
• Report Number: MW5100787
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: 15-1050
• Device Catalogue Number: 15-1050
• Device Lot Number: ''DD00C20224''
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 56 YR
• Patient Weight: 76