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

Lot Number 3000021033

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 02/29/2016

Event Type  Injury  

Event Description

Patient status post nstemi underwent cardiac cath on (b)(6) 2016, when the iabp was placed.On (b)(6), the balloon pump was alarming "catheter restriction." condensation, as well as specks of blood were noted in the helium line.Call placed to manufacturer recommended removal.Inspection of catheter noted a rupture of the balloon.

• Brand Name: MAQUET
• Type of Device: INTRA-AORTIC BALLOON CATHETER
• Manufacturer (Section D): MAQUET
• MDR Report Key: 5503801
• MDR Text Key: 40555969
• Report Number: MW5060910
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2018
• Device Lot Number: 3000021033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 92 YR
• Patient Weight: 64