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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0514
Device Problems Inflation Problem (1310); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2024
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 after a smooth insertion, the intra-aortic balloon (iab) was connected to the cs300 intra-aortic balloon pump (iabp).Upon connecting, the augmentation pressure did not rise.Suspecting poor balloon expansion, the catheter was replaced with a new one after 10 minutes.Therapy was continued without further issue.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also retuned.The inner lumen was found occluded with dried blood.The occlusion was able to be cleared.A sensor output test was performed and the sensor was found to be within specification.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 cardiosave pump and the iab fully inflated.No alarm sounded from the pump.The reported events cannot be confirmed by the evaluation.A 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
N/a.
 
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Brand Name
TRANS-RAY 7FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key18607154
MDR Text Key334103596
Report Number2248146-2024-00056
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/08/2024
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 Catalogue Number0684-00-0514
Device Lot Number3000295407
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/11/2024
Initial Date FDA Received01/30/2024
Supplement Dates Manufacturer Received03/08/2024
Supplement Dates FDA Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CS300.
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