MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0475

Device Problems Backflow (1064); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 01/21/2017

Event Type  Death  

Manufacturer Narrative

No decon or visual inspection performed since product was not returned.The product was not returned and so could not be evaluated.A lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.The complaint could not be confirmed.(b)(4).

Event Description

It was reported than an intra aortic balloon was inserted on (b)(6) 2017 because of patient ami.The balloon worked normally.On (b)(6) 2017 the pump alarmed "blood detect" and blood was found in tubing.The balloon was removed and because the patient was ok at that time the doctor did not insert the second balloon.The patient died on (b)(6) 2017.The death was not attributed to the device.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 6408067
• MDR Text Key: 70055769
• Report Number: 2248146-2017-00018
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/14/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000038041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/22/2017
• Date Device Manufactured: 10/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 65