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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 INTRA- AORTIC BALLOON FIBER OPTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problem Fluid Leak (1250)
Patient Problem Left Ventricular Dysfunction (1947)
Event Date 05/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported by the registered nurse (rn) in the cardiovascular intensive care unit (cvicu) that a patient had an intra- aortic balloon (iab) inserted via a sheath a week ago. The iabp alarmed helium loss last night and there was blood observed in the gas tubing. There were no complications to the patient. They were able to successfully remove the balloon with no issues last night. The patient is stable now without the pump. They did not replace the balloon.
 
Manufacturer Narrative
(b)(4). No product was returned for evaluation. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed. No product was returned for evaluation. If the product is returned at a later date, a full investigation will take place. The root cause of the complaint is undetermined.
 
Event Description
It has been reported by the registered nurse (rn) in the cardiovascular intensive care unit (cvicu) that a patient had an intra- aortic balloon (iab) inserted via a sheath a week ago. The iabp alarmed helium loss last night and there was blood observed in the gas tubing. There were no complications to the patient. They were able to successfully remove the balloon with no issues last night. The patient is stable now without the pump. They did not replace the balloon.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5670449
MDR Text Key45648444
Report Number1219856-2016-00119
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 05/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F15M0004
Other Device ID Number00801902034724
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 Received06/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2015
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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