MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; INTRA-AORTIC BALLOON

Model Number 0684-00-0434

Device Problem Invalid Sensing (2293)

Patient Problem Death (1802)

Event Date 09/05/2011

Event Type  Death  

Event Description

"blood detected" alarm with no visible blood in the tubing.They went through the help screen and powered down the pump.They were unable to restart pumping and the balloon has been in standby for 45 minutes.The fellow is on his way to pull the iab.Data sheet reported: balloon began to alarm "gas leak" no longer correctly augmenting.Iabp put on a pause by rn to troubleshoot.Iabp would not allow re-start.Maquet helpline called.Iabp paused >45min no restarted due to safety factors.Iab pulled by md.Patient deceased from other causes.

Manufacturer Narrative

Product condition received: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The returned sheath was over the catheter and partially covering the rear portion of the balloon.Five kinks were found on the catheter located approximately 41.4cm, 70.9c, 71.9cm, 75.4cm and 75.9cm from the iab tip.No blood was found inside the catheter.Product evaluation: an underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab ws placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.Conclusion: the reported problem could not be duplicated during testing.We are unable to determine when the kinds occurred, however if the kinks occurred during the procedure it could restrict the gas flow through the iab which could cause the reported alarm.A review of the device history does not indicate any lot specific issues.(b)(4).

• Brand Name: SENSATION 7FR. 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: 3947324
• MDR Text Key: 4642806
• Report Number: 2248146-2014-00203
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2014
• Device Model Number: 0684-00-0434
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 2601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/19/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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 Age: 53 YR