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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Material Rupture (1546); Noise, Audible (3273)
Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)
Event Date 10/22/2019
Event Type  malfunction  
Event Description
Patient had grafted axillary intra-aortic balloon pump (iabp) in place. Patient was sitting in the chair eating breakfast when he noticed the iabp was making a strange noise. He alerted his nurse who assessed that the balloon had ruptured, and blood was backing up into the helium line. The nurse paused the iabp, clamped the line and emergently notified the team. Patient was emergently brought back to bed and all pertinent teams came to bedside. Cts surgeon was at bedside and attempted to remove iabp through sheath with difficulty. During this the sheath pulled out of graft and the graft retracted back into the body and was bleeding into the patient. The surgeon did manage to get to the artery and control bleed. Patient was brought emergently to cath lab for new femoral iabp placement. Original iabp was an 8 french with 50 ml balloon; axillary placement. Replaced with 8 french, 50 ml femoral location.
 
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Brand NameIABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key9659330
MDR Text Key177378434
Report Number9659330
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/24/2019
Event Location Hospital
Date Report to Manufacturer02/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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