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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 INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Fluid Leak (1250); Material Rupture (1546)
Patient Problems Congestive Heart Failure (1783); Low Cardiac Output (2501)
Event Date 02/14/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). See also mdr #1219856-2017-00058.
 
Event Description
It was reported that the event involved a patient of (b)(6) in height. The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the cath lab. On (b)(6) 2017, the iab was repositioned by cardiology. The patient was sitting up later that evening when the balloon ruptured. Cardiology at bedside for iab removal/cut-down reversal. Patient was taken to the operating room (or) the following day for va-ecmo (ventricular assist-extracorporeal membrane oxygenation). Length of time in use prior to event was less than 13 days.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for analysis. The reported complaint of blood in helium pathway is confirmed. The iab was found kinked and the central lumen was found to be broken. The broken central lumen allowed blood to enter the helium pathway. The root cause of the kink is undetermined. A device history record (dhr) review was conducted with no relevant findings. Teleflex assessed the risk for the reported complaint and there are no new or revised risks. We will continue to monitor for trends. Other remarks: please refer to mdr #1219856-2017-00058/(b)(4) related to this complaint.
 
Event Description
It was reported that the event involved a patient of (b)(6) in height. The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the cath lab. On (b)(6) 2017, the iab was repositioned by cardiology. The patient was sitting up later that evening when the balloon ruptured. Cardiology at bedside for iab removal/cut-down reversal. Patient was taken to the operating room (or) the following day for va-ecmo (ventricular assist-extracorporeal membrane oxygenation). Length of time in use prior to event was less than 13 days.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6437442
MDR Text Key70969985
Report Number1219856-2017-00059
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 03/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F16G0030
Other Device ID Number00801802007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2016
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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