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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Difficult to Insert (1316); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2020
Event Type  malfunction  
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 record id # (b)(4).
 
Event Description
It was reported during insertion of the intra-aortic balloon(iab), customer stated that the membrane unraveled during insertion of the balloon.Opened a second balloon, which also the membrane unraveled during insertion of the balloon.The third balloon was opened and successfully placed.There was no reported injury to the patient.This report is for the 2nd balloon used.
 
Event Description
It was reported during insertion of the intra-aortic balloon(iab), customer stated that the membrane unraveled during insertion of the balloon.Opened a second balloon, which also the membrane unraveled during insertion of the balloon.The third balloon was opened and successfully placed.There was no reported injury to the patient.This report is for the 2nd balloon used.
 
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 record # (b)(4).
 
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Brand Name
SENSATION PLUS 8FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9635337
MDR Text Key187912501
Report Number2248146-2020-00050
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 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000105516
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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