MAUDE Adverse Event Report: MAQUET MAQUET MEGA IABP

Model Number 0684-00-0296-01U

Device Problems Occlusion Within Device (1423); Material Rupture (1546)

Patient Problems Death (1802); Pericardial Effusion (3271)

Event Date 12/30/2014

Event Type  Injury  

Event Description

Intra aortic balloon pump rupture during cath, inserted second iabp and clotted off.(b)(6) 2014 - left heart catheterization, left and right coronary angiogram, left internal mammary angiogram for worsening chest pain, significant st changes, hypotension.Increased hypotension during cath, 50 ml iabp placed, apparent rupture, placed second iabp clotted off.(b)(6) 2014 - ct of chest cardiomegaly, diffuse pulmonary infiltrate, edema versus pneumonitis, mild pericardial effusion.

• Brand Name: MAQUET MEGA IABP
• Type of Device: IABP
• Manufacturer (Section D): MAQUET
• MDR Report Key: 4408253
• MDR Text Key: 15315546
• Report Number: MW5040145
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2015

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 Expiration Date: 10/08/2017
• Device Model Number: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000002372
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 82