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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 Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2020
Event Type  malfunction  
Manufacturer Narrative
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.Complaint # (b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), a kink was observed on the iab catheter.The iab was removed and therapy was not provided because the patient's condition stabilized.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter with the one-way valve attached.One kink was found on the catheter tubing near the y-fitting approximately 75.9cm from the iab tip.The evaluation confirmed the kink in the catheter.We are unable to determine when this may have occurred.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 the insertion of an intra-aortic balloon (iab), a kink was observed on the iab catheter.The iab was removed and therapy was not provided because the patient's condition stabilized.There was no reported injury to the patient.
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), a kink was observed on the iab catheter.The iab was removed and therapy was not provided because the patient's condition stabilized.There was no reported injury to the patient.
 
Manufacturer Narrative
Additional information section d: unique identifier (udi) # from: [blank] to: (b)(4).Reference complaint (b)(4).
 
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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 Key10379102
MDR Text Key202197613
Report Number2248146-2020-00405
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,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/19/2023
Device Catalogue Number0684-00-0575
Device Lot Number3000115025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight71
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