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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0293
Device Problems Difficult to Insert (1316); Device Stops Intermittently (1599)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 02/09/2018
Event Type  Death  
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.(b)(4).
 
Event Description
The intra-aortic balloon (iab) was inserted during an emergency reopen in the icu (intensive care unit).Two days later while the patient was being prepared to go to the (operating) theater, it was noted that the iab pump was off.The pump was turned back on however only half screen came on; pump was turned off and on again and appeared to work.The balloon pump was not changed as patient was going to (operating) theater to have it removed.Once removed from patient, it was sent to biomed for testing and evaluation.There was no reported malfunction of the iab.Iab was inserted in the femoral artery in the right leg with cut down technique used, with reported difficulties during insertion; positioning was verified by x-ray.The indication for use was low blood pressure.The patient expired several days later, but the death was not attributed to the device by the facility.
 
Manufacturer Narrative
Updated from: yes to: no, to indicate that product is reported as not available to be returned for evaluation.Complaint # (b)(4), record # (b)(4).
 
Event Description
The intra-aortic balloon (iab) was inserted during an emergency reopen in the icu (intensive care unit).Two days later while the patient was being prepared to go to the (operating) theater it was noted that the iab pump was off.The pump was turned back on however only half screen came on; pump was turned off and on again and appeared to work.The balloon pump was not changed as patient was going to (operating) theater to have it removed.Once removed from patient, it was sent to biomed for testing and evaluation.There was no reported malfunction of the iab.Iab was inserted in the femoral artery in the right leg with cut down technique used, with reported difficulties during insertion; positioning was verified by x-ray.The indication for use was low blood pressure.The patient expired several days later, but the death was not attributed to the device by the facility.It was noted by the facility that the patient had a right leg amputation above the knee.After the surgery the surgeon suspected clots in the arm and left leg.The facility was not sure if the clots were arterial or venous.It was suggested by the surgeon there was a possible clot as the patient's foot turned blue and there were no pulses to the lower limb.There was no confirmation of a clot, but was assumed to be arterial as there was no blood flow to the foot.Cause of death was attributed to hypoxic brain injury.The patient had a very low blood pressure during reopen and after iab insertion despite inotropic support.The patient also had graft failure.
 
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Brand Name
MEGA 7.5FR. 40CC IAB
Type of Device
SYSTEM, 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 Key7321387
MDR Text Key101784225
Report Number2248146-2018-00149
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K120868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/13/2019
Device Catalogue Number0684-00-0293
Device Lot Number3000029035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received02/15/2018
Date Device Manufactured05/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Disability;
Patient Age69 YR
Patient Weight72
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