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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000252
Device Problems No Device Output (1435); Off-Label Use (1494); Failure to Zero (1683)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a teleflex sales rep. That an intra-aortic balloon (iab) fiber optic failure occurred. As a result, a new catheter was inserted via the axillary approach. There was no report of patient injury or consequence. This report would not be likely to cause or contribute to a death or serious injury. A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury. The fos is a portion of the catheter that monitors the patient's arterial pressure. When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen. Iab therapy continues to the patient uninterrupted. This system does not require the clinician to remove the iab in the event that the fos is lost. It was reported that the patient was going for a heart transplant. The iab would be inserted axillary approach. Per the instructions for use (ifu) this is an off label approach.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
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 Key9644169
MDR Text Key184478779
Report Number3010532612-2020-00007
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 01/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000252
Device Catalogue NumberIAB-05830-LWS
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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