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

Catalog Number 0684-00-0567

Device Problem Component Missing (2306)

Patient Problems Death (1802); No Information (3190)

Event Date 12/15/2016

Event Type  Death  

Manufacturer Narrative

The customer indicated that the device is not returning to the manufacturer and we are unable to complete an evaluation on the affected product.If additional information is provided or the product becomes available a supplemental report with our additional findings will be provided.(b)(4).

Event Description

It was reported when the surgery team opened the balloon kit, the one way valve was missing from the kit.Another kit was opened to replace the missing component.

Manufacturer Narrative

Intra aortic balloon support therapy was able to be given.It was reported that the patient died.The facility does not attribute the death to the device.(b)(4).

Event Description

It was reported when the surgery team opened the balloon kit, the one way valve was missing from the kit.Another kit was opened to replace the missing component.Additional information received - 1/10/2017: intra aortic balloon support therapy was able to be given.It was reported that the patient died.The facility does not attribute the death to the device.

• Brand Name: SENSATION PLUS 7.5FR. 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: 6230550
• MDR Text Key: 76853422
• Report Number: 2248146-2017-00001
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0684-00-0567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• 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