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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Insufficient Information (3190)
Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348); Needle Stick/Puncture (2462)
Event Date 10/11/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted for temporary help in the patient with cardiogenic shock and ventricular failure. The balloon worked properly, but then stopped and alarms were received. The staff performed "raz" and restarted each time. After a few unsuccessful tries, and the hemodynamic data of the patient were deteriorating, a second balloon was inserted in the right femoral. As a result, the iab was removed and a second iab was successfully used.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint that the iab/iabp "stopped and alarms were received" is not able to be confirmed. The root cause of the complaint is undetermined. If the product is returned at a later date, a full investigation of the sample will be completed. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted for temporary help in the patient with cardiogenic shock and ventricular failure. The balloon worked properly, but then stopped and alarms were received. The staff performed "raz" and restarted each time. After a few unsuccessful tries, and the hemodynamic data of the patient were deteriorating, a second balloon was inserted in the right femoral. As a result, the iab was removed and a second iab was successfully used.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9342878
MDR Text Key167021358
Report Number3010532612-2019-00410
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAB-05840-LWS
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No

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