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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problems Device Alarm System (1012); No Display/Image (1183); Failure to Zero (1683); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/23/2017
Event Type  malfunction  
Manufacturer Narrative
The iab was returned with the membrane completely unfolded. No blood was visible on the catheter. The technician was able to successfully aspirate/flush the inner lumen. The technician attempted to insert a laboratory 0. 025¿ guide wire through the inner lumen and was able to successfully insert the guide wire. No obstructions were felt. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. Complaint # (b)(4). Record # (b)(4).
 
Event Description
It was reported that a mega 50cc intra-aortic balloon catheter was used during intra-aortic balloon (iab) therapy due to heart failure. Before the connection to iab pump (iabp), blood was aspirated from the inner lumen for pressure monitoring set up. The zeroing of pressure line was normal at that time. After the iab was connected with the iabp, no arterial waveform was displayed. No alarm was detected at that moment as user was using auto mode (ecg signal was normal and used as triggering source). User found that no arterial waveform was shown so they recalibrated the pressure line. However, zeroing was unable to be performed while some numbers were displayed instead of "0". At the same time, they found that blood was unable to be aspirated from the inner lumen and suspected blood clot was formed. Finally iab was removed and inserted another one to continue the therapy. There was not patient injury reported.
 
Manufacturer Narrative
'lot number' changed from: 3000050639 to: 3000045495. Complaint # (b)(4).
 
Event Description
It was reported that a mega 50cc intra-aortic balloon catheter was used during intra-aortic balloon (iab) therapy due to heart failure. Before the connection to iab pump (iabp), blood was aspirated from the inner lumen for pressure monitoring set up. The zeroing of pressure line was normal at that time. After the iab was connected with the iabp, no arterial waveform was displayed. No alarm was detected at that moment as user was using auto mode (ecg signal was normal and used as triggering source). User found that no arterial waveform was shown so they recalibrated the pressure line. However, zeroing was unable to be performed while some numbers were displayed instead of "0". At the same time, they found that blood was unable to be aspirated from the inner lumen and suspected blood clot was formed. Finally iab was removed and inserted another one to continue the therapy. There was not patient injury reported.
 
Manufacturer Narrative
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. (b)(4).
 
Event Description
It was reported that a mega 50cc intra-aortic balloon catheter was used during intra-aortic balloon (iab) therapy due to heart failure. Before the connection to iab pump (iabp), blood was aspirated from the inner lumen for pressure monitoring set up. The zeroing of pressure line was normal at that time. After the iab was connected with the iabp, no arterial waveform was displayed. No alarm was detected at that moment as user was using auto mode (ecg signal was normal and used as triggering source). User found that no arterial waveform was shown so they recalibrated the pressure line. However, zeroing was unable to be performed while some numbers were displayed instead of "0". At the same time, they found that blood was unable to be aspirated from the inner lumen and suspected blood clot was formed. Finally iab was removed and inserted another one to continue the therapy. There was not patient injury reported.
 
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Brand NameMEGA 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7135468
MDR Text Key252104400
Report Number2248146-2017-00727
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2020
Device Catalogue Number0684-00-0497
Device Lot Number3000045495
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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