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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 Problems Inappropriate Waveform (2536); Optical Problem (3001)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/10/2022
Event Type  Injury  
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). Device not returned.
 
Event Description
The following was reported via medwatch report # (b)(4). A patient that presented with chest pain was sent to the cath lab where it was identified that he had severe multi-vessel coronary artery disease (cad) that would require a coronary artery bypass graft (cabg). The intra-aortic balloon (iab) was inserted for ongoing chest discomfort that could not be relieved with antianginals. It was reported that the fiber optic cable was not functioning properly and was unable to sense pressure or timing. They were unable to visualize the waveform or augment pressures. It was noted that the appropriate cables were not available to attach to the transducer. Approximately two days later, the patient was taken to the or where a transesophageal echocardiogram (tee) was completed and showed a possible aortic tear/dissection. A computed tomography angiograph (cta) of the chest identified an aortic injury that was not present on the ct scan completed prior to iab insertion. The cabg was cancelled and iab was removed.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key14223148
MDR Text Key290462154
Report Number2248146-2022-00330
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
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 Number3000176825
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/10/2022
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/27/2022 Patient Sequence Number: 1
Treatment
UNKNOWN PUMP.
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