MAUDE Adverse Event Report: COOPERSURGICAL, INC. ADVINCULA ARCH HANDLE

Model Number UMH750

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 12/22/2016

Event Type  malfunction  

Event Description

"this is the story: i placed the rumi with attached rumi tip, koh ring, and pneumoocluder, then inflated the tip balloon with 5 cc of ns and attached it to the ups.I then instructed the resident md to fill the occluder.Apparently, there was some confusion concerning the tubing to use for filling the occluder.The result was that the tip balloon was filled with 30-40 cc of air.This apparently popped the balloon, releasing air into the endometrial cavity, resulting in venous air embolism.The clinical manifestations were hypotension, transient hypoxia, and dramatic decrease in end-tidal co2." "clearly it was the use of this device contrary to the manufacture's recommendation that led to the adverse occurrence.Perhaps your engineering department can come up with some solution to decrease the possibility of recurrence? my thought was that a warning tag on the tubing or tags with larger lettering might be helpful." (b)(4).

• Brand Name: ADVINCULA ARCH HANDLE
• Type of Device: ADVINCULA ARCH HANDLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6392979
• MDR Text Key: 223164385
• Report Number: 1216677-2016-00094
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• PMA/PMN Number: K9321115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UMH750
• Device Catalogue Number: UMH750
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other