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

Catalog Number 0684-00-0575

Device Problems Air Leak (1008); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591); Torn Material (3024)

Patient Problem Death (1802)

Event Date 07/24/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Although good faith efforts have been attempted to retrieve the device, the device was not returned by the customer and so could not be evaluated.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) complaints has determined that the following adverse event reported on mdr 2248146-2016-00060 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.On (b)(6) 2016 during therapy, there was a "gas loss in circuit" generated.At that time, no blood was found, there was an auto fill and then the alarm.Upon inspection, the helium line and catheter were determined to have blood.The catheter was clamped to prevent the back flow of blood.A second catheter was going to be used for replacement, but was found to be torn.A third catheter was inserted successfully; however, the "gas loss in circuit" alarm was regenerated and blood was found in catheter and helium line.The line was removed and decided not to be replaced by the physician.The patient expired an hour after removal of 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: 6898876
• MDR Text Key: 87580523
• Report Number: 2248146-2017-00415
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000031049
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 07/24/2016
• Date Device Manufactured: 06/14/2016
• 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