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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Urinary Retention (2119)
Event Date 08/16/2016
Event Type  Injury  
Manufacturer Narrative
Date received by manufacturer: 08/17/2016.
 
Event Description
A sensation plus 40cc balloon was used on a patient and the following day the patients' urine output declined. They checked the iab placement and it migrated down 3 cm. The doctor advanced it and almost immediately migrated it back down; the iab was removed and the patients' vitals remained stable and urine output returned.
 
Manufacturer Narrative
The customer indicated that the product will not be returning to the manufacturer and we're unable to complete an evaluation on the affected product. If additional information becomes available a supplemental report with our additional findings will be sent. Complaint # (b)(4).
 
Event Description
A sensation plus 40cc balloon was used on a patient and the following day the patients' urine output declined. They checked the iab placement and it migrated down 3 cm. The doctor advanced it and almost immediately migrated it back down; the iab was removed and the patients' vitals remained stable and urine output returned.
 
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Brand NameSENSATION PLUS 7.5FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key5947376
MDR Text Key268765122
Report Number2248146-2016-00076
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Nursing Assistant
Type of Report Initial,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0567
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/13/2016 Patient Sequence Number: 1
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