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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-U
Device Problems Partial Blockage (1065); Gas/Air Leak (2946)
Patient Problems Calcium Deposits/Calcification (1758); Death (1802); No Consequences Or Impact To Patient (2199)
Event Date 02/23/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).For complaint related to the same events and patient see mdr #3010532612-2019-00085 and tc #(b)(4), mdr #3010532612-2019-00061 and tc #(b)(4), mdr #3010532612-2019-00063 and tc # (b)(4).
 
Event Description
It was reported that after the first intra-aortic balloon (iab) was removed, another iab was inserted.The doctor reported having another helium loss alarm and stated that the patient has significant calcification.Alarm strips were provided to the clinical support specialist (css), and discussed the partial obstruction noted on the balloon pressure waveform (bpw) and had the doctor decrease the volume to 38 cc.The doctor then informed the css that the volume was decreased to 36cc.The css informed the doctor to further decrease the volume, and it was decreased to 32cc and alarms have not occurred in some time (20 minutes).No blood was noted in the catheter tubing, timing was appropriate and the arterial waveform was good.On follow-up by the css, the rn informed her that the volume was decreased to 31cc, and the patient was weaning off the pump.Since weaning, no alarms in 1:2 or 1:4, and the staff went to 1:1 alarm did occur once.It was also reported that the patient was started on continuous renal therapy (crt) to unload some fluid off the patient.There was a report of patient death.The rn reported that the patient had an ejection fraction of 12% and was not a surgical candidate.The device did not cause or contribute to the patient's death.
 
Manufacturer Narrative
(b)(4).For complaint related to the same events and patient see mdr #3010532612-2019-00085 and tc #1900066632, mdr #3010532612-2019-00061 a nd tc #1900066633, mdr #3010532612-2019-00063 and tc #1900066635.Teleflex did not receive the device for investigation.The reported complaint of helium loss alarm is confirmed based on the customer pictures provided with the complaint report.The root cause of the helium loss alarm is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.A non-conformance has been initiated to further investigate the cause.
 
Event Description
It was reported that after the first intra-aortic balloon (iab) was removed, another iab was inserted.The doctor reported having another helium loss alarm and stated that the patient has significant calcification.Alarm strips were provided to the clinical support specialist (css), and discussed the partial obstruction noted on the balloon pressure waveform (bpw) and had the doctor decrease the volume to 38 cc.The doctor then informed the css that the volume was decreased to 36cc.The css informed the doctor to further decrease the volume, and it was decreased to 32cc and alarms have not occurred in some time (20 minutes).No blood was noted in the catheter tubing, timing was appropriate and the arterial waveform was good.On follow-up by the css, the rn informed her that the volume was decreased to 31cc, and the patient was weaning off the pump.Since weaning, no alarms in 1:2 or 1:4, and the staff went to 1:1 alarm did occur once.It was also reported that the patient was started on continuous renal therapy (crt) to unload some fluid off the patient.There was a report of patient death.The rn reported that the patient had an ejection fraction of 12% and was not a surgical candidate.The device did not cause or contribute to the patient's death.
 
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Brand Name
ULTRA 8 IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8429219
MDR Text Key139098742
Report Number3010532612-2019-00062
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902010759
UDI-Public00801902010759
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/23/2019
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 Date09/30/2020
Device Catalogue NumberIAB-05840-U
Device Lot Number18F18K0056
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/23/2019
Initial Date FDA Received03/18/2019
Supplement Dates Manufacturer Received04/24/2019
Supplement Dates FDA Received04/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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