MAUDE Adverse Event Report: MAQUET IABP BALLOON; INTRA - AORTIC BALLOON

Model Number 0684-00-0294-01U

Device Problems Break (1069); Entrapment of Device (1212); Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2017

Event Type  Injury  

Event Description

This is a (b)(6) y/o lady who was admitted on (b)(6), 2017 with complaints of chest tightness.She was diagnosed with a nstemi.She underwent a cardiac catheterization and an iabp was placed.On (b)(6), she went back to the cath lab to have a pci of the lad (95% occlusion) and left main (80% occlusion).On (b)(6) the iabp ruptured possibly due to the calcification in her aorta.When removing the balloon, a piece of the tip broke off and was retained.She was taken to the cath lab to attempt to remove the sheath and tip under fluoroscopy.Ultimately she had to be taken emergently to the operating room for removal by vascular surgery.

• Brand Name: IABP BALLOON
• Type of Device: INTRA - AORTIC BALLOON
• Manufacturer (Section D): MAQUET
• MDR Report Key: 6386877
• MDR Text Key: 69510181
• Report Number: MW5068328
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0684-00-0294-01U
• Device Lot Number: 3000015058
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2017
• 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): Required Intervention
• Patient Age: 77 YR