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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2019
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.(b)(4).
 
Event Description
It was reported that prior to intra-aortic balloon (iab) therapy, the t-handle retainer was difficult to remove.The iab was inserted before they realized the retainer was still on the iab.When attempts to remove the retainer were then unsuccessful, the iab was replaced and therapy resumed.There was no reported patient injury.
 
Manufacturer Narrative
Serial number - (b)(4) the product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.A penetration was observed along the catheter tubing from 33.0cm to 44.5 from the rear seal.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was confirmed along the catheter tubing.The penetration found in the catheter tubing appears to have been caused by a sharp instrument.A leak may impact the ability to maintain vacuum causing difficulty removing from the t-handle.The evaluation confirmed the reported problem.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 prior to intra-aortic balloon (iab) therapy, the t-handle retainer was difficult to remove.The iab was inserted before they realized the retainer was still on the iab.When attempts to remove the retainer were then unsuccessful, the iab was replaced and therapy resumed.There was no reported patient injury.
 
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Brand Name
LINEAR 7.5 FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8631936
MDR Text Key145775849
Report Number2248146-2019-00431
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2021
Device Catalogue Number0684-00-0474
Device Lot Number3000085180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Initial Date Manufacturer Received 05/02/2019
Initial Date FDA Received05/22/2019
Supplement Dates Manufacturer Received06/10/2019
Supplement Dates FDA Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age78 YR
Patient Weight68
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