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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Material Rupture (1546)
Patient Problems Chest Pain (1776); Blood Loss (2597)
Event Date 08/16/2018
Event Type  Injury  
Manufacturer Narrative
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 # (b)(4), record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was a ¿check iab catheter¿ alarm generated and blood was noted in tubing.The iab pump (iabp) was stopped, iab removed, and a new iab was inserted.Medwatch #mw5079332 was received by the manufacturer on 06-september-2018, reported for the iab, and states as follows: "patient underwent subclavian placement of an intra-arterial balloon pump (iabp) catheter.During the procedure, there was difficulty with the iabp catheter tracking.Subsequently the iabp catheter was removed after each attempt and a new one used for each attempt.The next date, the nurse noted blood in the catheter tubing.The patient was emergently taken to the cath-lab for replacement of the iabp catheter.The iabp catheter was found to have ruptured".Medwatch # mw5079337 received by the manufacturer on 06-september-2018, reported for the iabp, and states as follows: "patient underwent subclavian placement of the intra-arterial balloon pump (iabp).The next date, the "check iabp catheter" alarmed occasionally when patient sitting with head down slumping and stopped alarming when sitting up straight.When getting back to bed, the patient complained of pain in chest with movement.But went away once straightened out.The nurse noticed blood in the tubing.The patient was emergently taken to the cath-lab for replacement of the iabp catheter.The iabp catheter was found to have ruptured.A new iabp console was used.".
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was a ¿check iab catheter¿ alarm generated and blood was noted in tubing.The iab pump (iabp) was stopped, iab removed, and a new iab was inserted.Medwatch #mw5079332 was received by the manufacturer on 06-september-2018, reported for the iab, and states as follows: "patient underwent subclavian placement of an intra-arterial balloon pump (iabp) catheter.During the procedure, there was difficulty with the iabp catheter tracking.Subsequently the iabp catheter was removed after each attempt and a new one used for each attempt.The next date, the nurse noted blood in the catheter tubing.The patient was emergently taken to the cath-lab for replacement of the iabp catheter.The iabp catheter was found to have ruptured".Medwatch # mw5079337 received by the manufacturer on 06-september-2018, reported for the iabp, and states as follows: "patient underwent subclavian placement of the intra-arterial balloon pump (iabp).The next date, the "check iabp catheter" alarmed occasionally when patient sitting with head down slumping and stopped alarming when sitting up straight.When getting back to bed, the patient complained of pain in chest with movement.But went away once straightened out.The nurse noticed blood in the tubing.The patient was emergently taken to the cath-lab for replacement of the iabp catheter.The iabp catheter was found to have ruptured.A new iabp console was used.".
 
Manufacturer Narrative
Complaint reference (b)(4).Record id (b)(6).
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7872147
MDR Text Key120106962
Report Number2248146-2018-00545
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
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2021
Device Catalogue Number0684-00-0575
Device Lot Number3000075862
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 DA
Patient Weight98
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