MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-0800-53

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Loss of consciousness (2418)

Event Date 02/12/2017

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances noted in the dhr related to the reported event.

Event Description

It was reported by the customer: patient unresponsive, we did a cardiac intervention "after" case placed the iabp through an 8fr sheath very easily, plugged in and no ao waveform was present.Tried plugging fiber optic into a different iabp machine and no ao waveform was present.Further, it was reported the customer is not attributing the adverse event (i.E.Patient death) to the device.This is 2 of 2 reports for the same event.

Manufacturer Narrative

The company account manager for this facility reported that there was no malfunction of the pump at the time of the event, and it performed perfectly.Further, the said representative reported that the only issue was with the iab catheter, and that issue was with specifically the fiber optic sensor on the iab catheter.A separate report was submitted under medwatch #2248146-2017-00025 addressing this alleged iab malfunction.

Event Description

It was reported by the customer: patient unresponsive, we did a cardiac intervention "after" case placed the iabp through an 8fr sheath very easily, plugged in and no ao waveform was present.Tried plugging fiber optic into a different iabp machine and no ao waveform was present.Further, it was reported the customer is not attributing the adverse event (i.E.Patient death) to the device.This is 2 of 2 reports for the same event.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6465562
• MDR Text Key: 72062016
• Report Number: 2249723-2017-00018
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Other Device ID Number: CH246496L6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/30/2017
• Date Device Manufactured: 12/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 7.5FR. 40CC IAB.
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 66