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U.S. Department of Health and Human Services

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

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DATASCOPE CORPORATION SENSATION PLUS 8FR. 50CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0576-01U
Device Problems Material Puncture/Hole (1504); Gas Leak (2946)
Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Discomfort (2330)
Event Date 04/04/2021
Event Type  Injury  
Event Description
Balloon pump alarm noted: "no gas" and noted to not be inflating. All connections secure, no external evidence of leakage. Rn and charge rn at bedside. Md to bedside and requested another balloon for exchange of device. Upon removal of previously implanted balloon, noted to have large hole. Balloon placed in biohazard bad and saved as evidence of equipment failure. Pt remained generally hemodynamically stable, although there was a significant drop in sbp while balloon out. Pt required emergent bedside surgery to repair femoral artery. Patient a is a (b)(6) year-old lady with no previous cardiac history. She present today for chest discomfort, dyspnea on exertion. She started noticing dyspnea exertion, chest discomfort when she was walking around 1 week ago. Denies resting symptoms. No orthopnea, no pnd, no presyncope or syncope. She went to see her pcp earlier today as scheduled. An ekg was done, which was concerning for acute coronary syndrome. She was sent to emergency room immediately. She is resting without distress when i saw her. No chest pain, no chest pressure, no orthopnea, no pnd. Her ekg showed st depression, but no indication of stemi. She has been hemodynamics stable. Troponin is mildly elevated. Fda safety report id #: (b)(4).
 
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Brand NameSENSATION PLUS 8FR. 50CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORPORATION
fairfield NJ 07004
MDR Report Key11633813
MDR Text Key244701030
Report NumberMW5100645
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0576-01U
Device Lot Number3000135059
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/07/2021 Patient Sequence Number: 1
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