MAUDE Adverse Event Report: MAQUET MAQUET; INTRAAORTIC BALLOON PUMP

Catalog Number 0684-00-0480-01U

Device Problems Material Rupture (1546); Device Contamination with Body Fluid (2317)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Code Available (3191)

Event Date 04/06/2018

Event Type  Injury  

Event Description

Iabp inserted after resuscitative efforts on (b)(6) 2018.On (b)(6) 2018, blood noted in helium line and balloon found to have ruptured.Patient with history of esrd, pe on coumadin, and had a mitral valve rupture.For valve surgery when case was cancelled due to her instability and hypotension.An iabp was placed to maintain hemodynamics by the cardiothoracic team, while in the csu (cardiothoracic surgery unit), the balloon was found to be ruptured.

• Brand Name: MAQUET
• Type of Device: INTRAAORTIC BALLOON PUMP
• Manufacturer (Section D): MAQUET; wayne NJ 07470
• MDR Report Key: 7432327
• MDR Text Key: 105723210
• Report Number: MW5076502
• Device Sequence Number: 1
• Product Code: DSP
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Catalogue Number: 0684-00-0480-01U
• Device Lot Number: 3000070409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• 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): Life Threatening
• Patient Age: 67 YR