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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; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problems Restricted Flow rate (1248); Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Event site zip code: (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.Complaint record id # (b)(4).
 
Event Description
It was reported that on the third day of intra-aortic balloon (iab) therapy, the console generated an iab catheter required inspection alarm.After the alarm sounded, it was noticed that the arterial pressure waveform was flat.Because the patient was finishing up iab therapy when the event occurred, the iab was removed safely.There was no reported injury to the patient.
 
Event Description
It was reported that on the third day of intra-aortic balloon (iab) therapy, the console generated an iab catheter required inspection alarm.After the alarm sounded, it was noticed that the arterial pressure waveform was flat.Because the patient was finishing up iab therapy when the event occurred, the iab was removed safely.There was no reported injury to the patient.
 
Manufacturer Narrative
Approximately 74.17 cm, 74.93 cm and 76.2 cm from the iab tip.The optical fiber was found to be broken within the membrane at 23.62 cm.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was unable to insert the guide wire.The inner lumen was discovered to be occluded with blood and could not be cleared.An underwater leak test of the balloon, catheter, y-fitting, inner lumen, extracorporeal tubing, pressure tubing, and extender tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped but was unable to pump to 90% volume.The condition of the iab as received indicated three kinks on catheter tubing.Even though we did not replicate the reported alarm, a kink can cause the issue.We are unable to conclusively determine when these kinks may have occurred.The optical fiber was found to be broken confirming the difficulty to pressure monitor.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 on the third day of intra-aortic balloon (iab) therapy, the console generated an iab catheter required inspection alarm.After the alarm sounded, it was noticed that the arterial pressure waveform was flat.Because the patient was finishing up iab therapy when the event occurred, the iab was removed safely.There was no reported injury to the patient.
 
Manufacturer Narrative
Return to manufacture date, date received by mfg, device not eval provide code,evaluation method codes ,evaluation result codes, evaluation conclusion codes, addtl mfg narrative/corr.Data.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.Complaint #: (b)(4).
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9779919
MDR Text Key186140448
Report Number2248146-2020-00133
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 06/17/2020
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 Date05/01/2022
Device Catalogue Number0684-00-0605
Device Lot Number3000095707
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 02/17/2020
Initial Date FDA Received03/03/2020
Supplement Dates Manufacturer Received05/12/2020
06/17/2020
Supplement Dates FDA Received05/14/2020
06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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