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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 Image Display Error/Artifact (1304); Failure to Read Input Signal (1581)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the registered nurse that the intra-aortic balloon (iab) catheter was inserted without difficulty, fiber optic arterial pressure (ap) waveform was present, zeroed, but the waveform was "not normal" and fiber optic messages including calibration key missing and corrupt continued to happen. The rn exchanged the intra-aortic balloon pump (iabp) but still had the same issues. As a result, a second iab catheter was inserted into the same insertion site. 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
9782505100
MDR Report Key9953494
MDR Text Key187561072
Report Number3010532612-2020-00100
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 03/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F19A0029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2019
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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