MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problems Device Displays Incorrect Message (2591); Calibration Problem (2890)

Patient Problems Bradycardia (1751); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 02/07/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The product was discarded and will not be available for an evaluation.If additional information is supplied a supplemental report will be sent.(b)(4).

Event Description

(b(4).This was a stemi patient that after the pci procedure his heart rate and bp started dropping.Then cpr was started and they inserted the sensation 40 iab.At first the pump stated no trigger and the staff put on the ecg leads, then the pump stated optical sensor failure/ or unable to calibrate optical sensor.They continued the cpr and then they wanted to try putting the impella into the patient, but patient deceased.They did not save the catheter.

Manufacturer Narrative

Correction: date was not entered in the initial mdr.Date: (b)(6) 2016.

Event Description

On (b)(6) 2016 05:47 pm (gmt-5:00) added by trackwise webservices (cpl) (tws): this was a stemi patient that after the pci procedure his heart rate and bp started dropping.Then cpr was started and they inserted the sensation 40 iab.At first the pump stated no trigger and the staff put on the ecg leads, then the pump stated optical sensor failure/ or unable to calibrate optical sensor.They continued the cpr and then they wanted to try putting the impella into the patient, but patient deceased.They did not save the catheter.

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• MDR Report Key: 5485130
• MDR Text Key: 39839600
• Report Number: 2248146-2016-00023
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/10/2016
• 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 Age: 60 YR