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

Model Number 0684-00-0497

Device Problem Invalid Sensing (2293)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Issues with iab pump not being able to update timing.After assessing the situation, the chief perfusionist told me he thought that the catheter was not in the correct position within the aorta.Datasheet reported: patient expired not because of iab.

Manufacturer Narrative

Product condition received: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The pressure tubing was also returned.Product evaluation: an underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents on complete autofill cycle.The iab pump normally and no alarm sounded form the pump.Conclusion: the reported events cannot be confirmed by the evaluation.A review of the device history does not indicate any lot specific issues.(b)(4).

• Brand Name: LINEAR 7.5FR 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 07004-0011 ; 9737097256
• MDR Report Key: 3947299
• MDR Text Key: 18573978
• Report Number: 2248146-2014-00199
• 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: 07/28/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2014
• Device Model Number: 0684-00-0497
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 2600
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2011
• 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: 54 YR