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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problems Filling Problem (1233); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2019
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 that during intra-aortic balloon (iab) therapy, the autofill was not working. The customer removed the balloon and the balloon was kinked. The insertion was reported to be axillary, which is not the method described in the device instructions for use. There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. One kink was found on the catheter tubing approximately 32. 5cm from the iab tip. An underwater leak test of the balloon, catheter, y-fitting extracorporeal, and extender tubing was performed and no leaks were detected. The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle. The iab pumped normally and no alarm sounded from the pump. The evaluation determined there was a kink in the catheter. It is difficult to determine when or how a kink in the catheter occurs. Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm. A device and lot history record review was completed for the reported product. No nonconformances were found that are considered to be related to the event. Reference complaint #(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the autofill was not working. The customer removed the balloon and the balloon was kinked. The insertion was reported to be axillary, which is not the method described in the device instructions for use. There was no reported injury to the patient.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8649673
MDR Text Key146361126
Report Number2248146-2019-00439
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/20/2021
Device Catalogue Number0684-00-0434
Device Lot Number3000072317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

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