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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. 35CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problem Pressure Problem (3012)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 11/28/2019
Event Type  Injury  
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#: (b)(4).
 
Event Description
It was reported that the patient's blood pressure decreased, and intra-aortic balloon pump (iabp) therapy was initiated again using a second balloon catheter.The same issue was reported where the arterial pressure waveform again appeared unstable.The intra-aortic balloon pump (iabp) unit was swapped out with a cs300 iabp; however, the issue persisted.Subsequently, the arterial pressure waveform has become stable and the patient had been reported in stable condition under iabp therapy.The patient's aortic arch was reported to be heavily tortuous and calcified.This report is for the second balloon used.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the catheter and the returned maquet sheath.Two catheter tubing kinks were observed at approximately 42.2cm and 73.4cm from the iab tip.A laser test of the optical fiber was performed and break was observed within the sensor cable at approximately 177.8cm from the rear of the y-fitting.The optical fiber was found to be broken, confirming the reported problem.However, we are unable to determine when this may have occurred.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.Complaint record # (b)(4).
 
Event Description
It was reported that the patient's blood pressure decreased, and intra-aortic balloon pump (iabp) therapy was initiated again using a second balloon catheter.The same issue was reported where the arterial pressure waveform again appeared unstable.The intra-aortic balloon pump (iabp) unit was swapped out with a cs300 iabp; however, the issue persisted.Subsequently, the arterial pressure waveform has become stable and the patient had been reported in stable condition under iabp therapy.The patient's aortic arch was reported to be heavily tortuous and calcified.This report is for the second balloon used.
 
Manufacturer Narrative
Updated sections: b4, g4, g7, h10.Corrected section: h1 - 'type of reportable event' changed from malfunction to serious injury.
 
Event Description
It was reported that the patient's blood pressure decreased, and intra-aortic balloon pump (iabp) therapy was initiated again using a second balloon catheter.The same issue was reported where the arterial pressure waveform again appeared unstable.The intra-aortic balloon pump (iabp) unit was swapped out with a cs300 iabp; however, the issue persisted.Subsequently, the arterial pressure waveform has become stable and the patient had been reported in stable condition under iabp therapy.The patient's aortic arch was reported to be heavily tortuous and calcified.This report is for the second balloon used.
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 35CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9491170
MDR Text Key185605815
Report Number2248146-2019-00936
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 company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/04/2022
Device Catalogue Number0684-00-0604
Device Lot Number3000093378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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