MAUDE Adverse Event Report: TERUMO TERUMO ANGIOSEAL VIP

Model Number REF 610130

Device Problems Positioning Failure (1158); Device Inoperable (1663)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 07/10/2017

Event Type  Injury  

Event Description

A terumo angioseal vip device was attempted to be deployed post coronary diagnostic catheterization for hemostatis - device malfunctioned w/collagen plug unable to be deployed and the foot of the device remained in place.Manual pressure was then applied to pt's r femoral artery access site (5 fr sheath was used) to achieve hemostasis.

• Brand Name: TERUMO ANGIOSEAL VIP
• Type of Device: TERUMO ANGIOSEAL VIP
• Manufacturer (Section D): TERUMO; somerset NJ 08873
• MDR Report Key: 6724639
• MDR Text Key: 80556203
• Report Number: MW5071088
• Device Sequence Number: 1
• Product Code: MGB
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 610130
• Device Lot Number: 5959823
• 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; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 96