MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0433

Device Problem Filling Problem (1233)

Patient Problem Death (1802)

Event Date 06/20/2019

Event Type  Death  

Manufacturer Narrative

(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated an autofill failure alarm.The customer changed the helium bottle but the alarm continued.Customer changed the console but same alarm was generated.A new balloon was inserted and same autofill failure alarm was generated.It was reported that the patient expired.This report is for second iab used.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated an autofill failure alarm.The customer changed the helium bottle but the alarm continued.Customer changed the console but same alarm was generated.A new balloon was inserted and same autofill failure alarm was generated.It was reported that the patient expired.This report is for second iab used.

Manufacturer Narrative

An evaluation of the pictures provided by the customer confirm the "autofill failure" alarm.Reference complaint #(b)(4).

• Brand Name: SENSATION 7FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8803900
• MDR Text Key: 151480300
• Report Number: 2248146-2019-00609
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR