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 05/30/2011

Event Type  Death  

Event Description

Console alarmed "blood detected," but none was noted in gas line.Balloon was pulled from patient.Datasheet reported: patient expired on (b)(6) 2011 but datasheet checked "unknown" if patient condition a result of the event.Follow-up on (b)(6) 2011 confirmed that patient had a condition that was considered a contraindication (aortic insufficiency) per the ifu.Follow up on (b)(6) 2011 with the person that filled out the complaint indicated that the patient death was not attributed to the product.

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.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 iab pumped normally and no alarm sounded from 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 7.5 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: 4027634
• MDR Text Key: 4843599
• Report Number: 2248146-2014-00165
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2014
• Device Model Number: 0684-00-0475
• Device Catalogue Number: 0684-00-0480-02
• Device Lot Number: 2573
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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: 82 YR
• Patient Weight: 98