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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE 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 Failure to Select Signal (1582)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2018
Event Type  malfunction  
Manufacturer Narrative
Distributor name: (b)(4).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 the intra-aortic balloon (iab) was inserted into an acute myocardial infarction (ami) patient.Iab optical sensor disappeared from the display once the surgeon attached a statlock on the patient.Replaced iab to continue therapy.No patient injury reported.Mild sclerosis and tortuosity were noted in the patient vessel.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender and pressure tubing were also returned.The optical fiber was found to be broken within the catheter tubing near the y-fitting approximately 76.2cm from the iab tip.The optical fiber was found to be broken, confirming the reported problems.It is difficult to determine when or how a break in the fiber optic occurs.However, a kink in the catheter can cause the fiber optic to break resulting in no signal, the inability to calibrate it or an alarm.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.(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted into an acute myocardial infarction (ami) patient.Iab optical sensor disappeared from the display once the surgeon attached a statlock on the patient.Replaced iab to continue therapy.No patient injury reported.Mild sclerosis and tortuosity were noted in the patient vessel.
 
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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 FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7949155
MDR Text Key123208918
Report Number2248146-2018-00576
Device Sequence Number0
Product Code DSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2020
Device Catalogue Number0684-00-0605
Device Lot Number3000059179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2018
Device AgeYR
Date Manufacturer Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number0
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