MAUDE Adverse Event Report: DATASCOPE CORP LINEAR 7.5 FR. 40CC IAB; INTRA-AORTIC BALLOON

Model Number 0684-00-0475

Device Problem Invalid Sensing (2293)

Patient Problem Death (1802)

Event Date 03/11/2011

Event Type  Death  

Event Description

"blood back" alarm and "check iab catheter" alarm sounded after 10 minutes.Another pump was used and linear catheter was replaced.Pt had previous iab inserted via aorta.This iab was removed to close pt chest.Pt destabilized.New iab inserted into aorta.Iabp alarm: system leak and rapid gas loss.Changed iabp.Alarm persisted.Changed out iab worked fine.Pt died 3 days later.

Manufacturer Narrative

Product condition received: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.No blood was observed inside the balloon, catheter, or extracorporeal tubing.One kink was found near the y-fitting approx 76.2cm from the tip.Product evaluation: an underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The kink was induced and the iab pumped normally and no alarm sounded from the pump.Conclusion: the returned product was tested and reported alarms could not be duplicated.(b)(4).

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): DATASCOPE CORP; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3931246
• MDR Text Key: 15935881
• Report Number: 2248146-2014-00115
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 0684-00-0475
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 2554
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2011
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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
• Patient Weight: 79