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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 Problems Device Alarm System (1012); Fluid Leak (1250); Material Rupture (1546)
Patient Problem Atherosclerosis (1728)
Event Date 03/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that an intra-aortic balloon (iab) was placed in the patient from the axillary position secondary to severe atherosclerosis in the femoral. The clinical support specialist (css) spoke with the perfusionist because he was getting some helium loss alarms. He was able to decrease the volume of the iab and the alarms went away. I reminded him that there may be an increase in iab abrasions with this alternate insertion. I asked him to remind the nurses to be very diligent in monitoring the helium drive line tubing for any evidence of blood. A call was received by the register nurse and the nurse described flecks in the helium drive-line tubing and i agreed that the only way for the flecks to be there was with compromise to the iab membrane and the catheter would need to come out. It was reminded that with this alternate insertion site and the patient with known severe atherosclerosis, he was at increased risk for an abrasion. I reminded him that any blood in the tubing had to come from a hole in the balloon itself, and the catheter needed to come out now. The medical doctor took the catheter out. There was no reported patient death.
 
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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
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7452112
MDR Text Key106213134
Report Number3010532612-2018-00084
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17B0035
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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