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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problem Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2019
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.(b)(4).
 
Event Description
It was reported that three days into intra-aortic balloon (iab) therapy, blood was found in the helium tubing and that the balloon had ruptured.It was reported that the catheter required surgical removal.Medwatch form reference: mw5084121; received on march 4, 2019.
 
Manufacturer Narrative
Section h6 - evaluation method codes: [to]: analysis of production records; 3331.Reference complaint #: (b)(4); record id (b)(4).
 
Event Description
It was reported that three days into intra-aortic balloon (iab) therapy, blood was found in the helium tubing and that the balloon had ruptured.It was reported that the catheter required surgical removal.Medwatch form reference: mw5084121 received on march 4, 2019.
 
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Brand Name
SENSATION PLUS 7.5FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8416458
MDR Text Key138675865
Report Number2248146-2019-00204
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
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/14/2021
Device Catalogue Number0684-00-0567
Device Lot Number3000084492
Was Device Available for Evaluation? Yes
Device Age YR
Date Manufacturer Received03/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age66 YR
Patient Weight101
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