MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problem Air Leak (1008)

Patient Problem Death (1802)

Event Date 09/09/2016

Event Type  Death  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

An internal review of intra-aortic balloon (iab) pump complaints has determined that the following adverse event reported on mdr 2249723-2016-00029 also involved the iab catheter in this event which was not previously reported on mdr.As a result, this case is being reopened and reported now.There was a reported death that was not attributed to the device: this is complaint is for the balloon only.The two pump cases are referenced.After changing the device, they had a air leakage alarm.They checked the right position with rx and tee then the iab with a syringe to be sure it did not have blood inside the iab.

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 6802268
• MDR Text Key: 82976823
• Report Number: 2248146-2017-00310
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/17/2018
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000019463
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 09/09/2016
• Date Device Manufactured: 11/17/2015
• 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: 82 YR
• Patient Weight: 79