MAUDE Adverse Event Report: DATASCOPE CORP; INTRA-AORTIC BALLON

Device Problem Balloon rupture (1049)

Patient Problem Death (1802)

Event Date 02/25/2011

Event Type  Death  

Event Description

While pumping on a pt, the balloon ruptured and drew blood back into the pump.On (b)(6) 2011, it was stated by emergency room from the facility where the incident occurred, "the pt died, but his death was not directly related to the pump or the catheter.Pt was very very sick".

Manufacturer Narrative

The product was returned for evaluation.Internal file number (b)(4).

• Type of Device: INTRA-AORTIC BALLON
• Manufacturer (Section D): DATASCOPE CORP; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3885488
• MDR Text Key: 4650913
• Report Number: 2248146-2014-00105
• 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: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2011
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death