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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 Difficult to Insert (1316); Unraveled Material (1664)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/24/2019
Event Type  malfunction  
Manufacturer Narrative
Additional initial reporter - (b)(6), assistant nurse manager.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.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the balloon was opened and removed from the t-handle.The customer noticed the iab was not properly wrapped and there was difficulty to insert iab through the sheath.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
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.Reference complaint # (b)(4); record id (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the balloon was opened and removed from the t-handle.The customer noticed the iab was not properly wrapped and there was difficulty to insert iab through the sheath.The iab was replaced to continue therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
The iab was returned with the membrane completely unfolded with the one-way valve attached.No blood was visible on the catheter.The sheath was not returned for evaluation.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.An evaluation of the product was unable to duplicate the reported problem.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.Reference complaint #: (b)(4); record id: (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion, the balloon was opened and removed from the t-handle.The customer noticed the iab was not properly wrapped and there was difficulty to insert iab through the sheath.The iab was replaced to continue therapy.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 Key8522640
MDR Text Key142522447
Report Number2248146-2019-00298
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,foreig
Type of Report Initial,Followup,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/10/2021
Device Catalogue Number0684-00-0575
Device Lot Number3000081750
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Device Age YR
Date Manufacturer Received06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age67 YR
Patient Weight97
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