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

Catalog Number 0684-00-0433

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 04/11/2016

Event Type  Death  

Manufacturer Narrative

The device has not been returned to the manufacturer and we're unable to complete an evaluation on the affected product.When its' provided we will send a supplemental report with additional findings - we continue in our efforts to follow up with the customer for its' return.(b)(4).

Event Description

Balloon inserted in patient on (b)(6).Patient in cticu on (b)(6) awaiting bypass surgery.Blood seen in the balloon pump tubing 7am (b)(6).Alarms observed were "low helium" balloon removed in cticu.Patient became unstable and was to be taken emergently to surgery but expired in cticu.

Manufacturer Narrative

Date received by mfr: 04/19/2016.

Event Description

Balloon inserted in patient on (b)(6).Patient inct icu on (b)(6) awaiting bypass surgery.Blood seen in the balloon pump tubing 7am (b)(6).Alarms observed were "low helium" balloon removed in cticu.Patient became unstable and was to be taken emergently to surgery but expired in cticu.

• Brand Name: SENSATION 7FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• MDR Report Key: 5661199
• MDR Text Key: 45364857
• Report Number: 2248146-2016-00045
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

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 Expiration Date: 06/01/2015
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000010207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: 04/19/2016
• Supplement Dates FDA Received: 01/31/2018
• 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: 77 YR