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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
Model Number IPN000254
Device Problems Material Puncture/Hole (1504); Insufficient Flow or Under Infusion (2182); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the staff received 3 possible helium loss 2 alarms in 10 minutes when the intra-aortic balloon (iab) was in use. No blood was noted in the driveline tubing, no visible kinks, and occasional ectopy. Patient's pressures have remained stable during all alarms and pauses in pumping. The staff received a high baseline alarm. Pumping resumed without issue. As a result, the iab was swapped out and the same insertion site was used. There was no report of patient complications, serious injury or 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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key10517675
MDR Text Key206496652
Report Number3010532612-2020-00248
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 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20C0034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2020
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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