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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE / DATASCOPE CORP. SENSTION PLUS 7.SFR 40CC INTRA AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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GETINGE / DATASCOPE CORP. SENSTION PLUS 7.SFR 40CC INTRA AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number MAQUET SENSATION P1
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problems Atrial Fibrillation (1729); Death (1802); Myocardial Infarction (1969); Ventricular Tachycardia (2132)
Event Date 02/05/2021
Event Type  Death  
Event Description
Nstemi complicated by vt arrest. Coronary angiogram demonstrated severe multivessel disease. Iabp placed. On (b)(6) 2021, patient experienced labile blood pressures and at 7 pm required increasing vasopressors. Onset of afib with increasing ectopy (pac's, pvc's. Iabp began to alarm with messages: check catheter position" and "auto r wave deflation. " cpr was initiated. At end of cpr, small amount of blood noted in helium line. Patient in pulseless vt despite on-going efforts and family consulted. Decision made to transition to comfort measures only and resuscitation discontinued. Upon removal of catheter/balloon, small hole in balloon noted. The patient presented urgently with nstemi, elevation in cardiac biomarkers and continuing symptoms despite aggressive anti-anginal therapy.
 
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Brand NameSENSTION PLUS 7.SFR 40CC INTRA AORTIC BALLOON CATHETER
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
GETINGE / DATASCOPE CORP.
MDR Report Key11384879
MDR Text Key233979075
Report NumberMW5099641
Device Sequence Number1
Product Code DSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMAQUET SENSATION P1
Device Lot Number5649979
Was Device Available for Evaluation? Yes
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: 02/25/2021 Patient Sequence Number: 1
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