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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problem Leak/Splash (1354)
Patient Problems Thrombus (2101); Cardiogenic Shock (2262); Respiratory Failure (2484); Thrombosis/Thrombus (4440)
Event Date 01/04/2021
Event Type  Death  
Manufacturer Narrative
Complete initial reporter name - (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, while the registered nurse was in the room assessing the patient, he witnessed blood backing up into the helium line. Before the iabp console started alarming he was assessing and troubleshooting and placed the pump on standby. He quickly got the necessary staff into the room to help. The doctors o all saw patient at bedside when the event occurred and assumed the balloon had ruptured. Plans were made quickly for the patient to go to cath lab to replace intra-aortic balloon(iab). Patient was sitting in bed, stable, with bipap on prior to event. Patient was coughing violently about 10 minutes prior to helium line filling with blood. Patient was immediately intubated and taken to the operating room within the hour for intra-aortic balloon(iab) replacement. Per the operating room team, found intra-aortic balloon(iab) intact but the wire in the balloon found to be broken. The pa and surgeon in the cath lab both mention in their op notes that there was a thrombus in the patient's axillary hemoshield graft. A thrombectomy was performed and the iabp exchanged. The exchange of the wire was not possible because it goes into the iab through the ruptured part inside the balloon. Then we opened the skin to take the insertion sheath and then we passed a #6 fogarty catheter to perform the embolectomy. We could retrieve most of the clots.
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, 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
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key11251607
MDR Text Key229360809
Report Number2248146-2021-00053
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000127407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2020
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: 01/29/2021 Patient Sequence Number: 1
Treatment
#6 FOGARTY CATHETERCARDIOSAVE
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