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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 Puncture/Hole (1504)
Patient Problems Cardiogenic Shock (2262); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)
Event Date 02/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the chief of perfusion that a patient with an intra-aortic balloon (iab) ruptured. The rupture occurred approximately an hour ago in the cardiovascular intensive care unit (cvicu). Blood was noted in the tubing just prior to an unspecified alarm on the intra-aortic balloon pump (iabp). The iab was removed without incident or noted complication. The md chose not to reinsert at this time. The iab was inserted pre-op in the cath lab and later the patient was also placed on extracorporeal membrane oxygenation (ecmo) life support. The patient is currently critical and supported on ecmo. The chief of perfusion reports worsening pulses to the foot over the last 24hours but is not convinced this was isolated to the iab/iabp, patient has no previous peripheral vascular disease (pvd) history. He is wondering how much the ecmo aortic cannula could have affected or caused the iab rupture. There is no patient death reported, however, patient current condition is critical. Iab was removed and therapy terminated. Per additional note: chief of perfusion, stated that the iab event did not cause any known complications or contribution to patient's current critical status.
 
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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 Key7346318
MDR Text Key102723333
Report Number3010532612-2018-00045
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 02/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17K0038
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2017
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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