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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2024
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6).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 the day after inserting the intra-aortic balloon (iab), the doctor was informed that the console had stopped and indicated a fiber optic sensor failure.No alarm record was noted in the log.When the doctor went to check, the console was working as expected.They believe the pressure readings may not have been displayed.The iab was removed after two days of therapy.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 and between the catheter and the sheath.The returned sheath was not a maquet product.The extender tubing was also returned.A kink was found on the catheter tubing and inner lumen approximately 76.5cm from the iab tip.The optical fiber was found to be broken within the membrane approximately 23.9cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was able to be cleared.The optical fiber was found to be broken, confirming the reported problem.We are unable to determine when this may have occurred.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 PLUS 7.5 FR. 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 Key18686015
MDR Text Key336183199
Report Number2248146-2024-00080
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/11/2024
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 Number0684-00-0605
Device Lot Number3000304521
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received02/12/2024
Supplement Dates Manufacturer Received03/11/2024
Supplement Dates FDA Received03/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
THIRD-PARTY SHEATHS
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