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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Coagulation in Device or Device Ingredient (1096); Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the central lumen of the catheter was clotted.The patient is still being supported by the therapy.There is no issue with the fiber optics or pump.The iab is functioning fine with a good tracing.There was no reported injury to the patient.
 
Manufacturer Narrative
Device manufacturers only device codes changed partial blockage 1065 to obstruction of flow 2423.The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.The technician was able to successfully aspirate/flush the inner lumen.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation.The product performed according to specification.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.Complaint # (b)(4), record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the central lumen of the catheter was clotted.The patient is still being supported by the therapy.There is no issue with the fiber optics or pump.The iab is functioning fine with a good tracing.There was no reported injury to the patient.
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8540804
MDR Text Key142957440
Report Number2248146-2019-00315
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 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/24/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000088929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Device Age YR
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight77
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