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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 IPN039787
Device Problems Failure to Zero (1683); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This complaint is reportable due to the decision to exchange the iab catheter to continue therapy, which can result in delay in patient therapy and harms. However, 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.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab) the fos did not connection. As a result, another iab was used for treatment. There was a delay in treatment. 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 Key10250010
MDR Text Key198094929
Report Number3010532612-2020-00187
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberIPN039787
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20C0052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2020
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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