MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

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

Patient Problem Death (1802)

Event Date 06/21/2019

Event Type  Death  

Manufacturer Narrative

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. (b)(4).

Event Description

Reported via medsun # (b)(4) received by getinge on 7/29/2019: the patient was transferred from the intensive care unit to the cath lab for impella placement with intra-aortic balloon (iab) catheter in place and the console was being used on battery. Upon arrival to the cath lab, the iab console shut off. The console was immediately plugged into an outlet and the device came on but was not functioning properly. The staff was unable to palpate pulses and cardiopulmonary resuscitation was initiated. The patient was initially admitted in cardiogenic shock, status post st elevation myocardial infarction and underwent a mitral valve replacement and coronary artery bypass grafting x3. Post-operatively, the patient was on multiple vasoactive infusions and was extremely unstable. The impella device was successfully placed the same day, but was reported to be a last ditch effort. The patient expired the next day, post-operatively day 4. The facility reported that the iab console failure was not believed to be a contributing factor in the patient's death. This report is for the iab catheter, for which there was no reported malfunction.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8914994
• MDR Text Key: 155028584
• Report Number: 2248146-2019-00703
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0684-00-0474
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/21/2019 Patient Sequence Number: 1