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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
Catalog Number IAB-05830-LWS
Device Problems Device Alarm System (1012); Fluid Leak (1250); Material Rupture (1546)
Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)
Event Date 02/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the event occurred in the cardiovascular intensive care unit (cvicu), the patient was being supported with the intra-aortic balloon pump (iabp). The physician stated that the intra-aortic balloon (iab) had ruptured after insertion and after the patient was transferred to the cvicu. The pump alarmed "possible helium loss" and blood was noted in the helium driveline. As a result the physician removed the iab and was replaced with a second iab to continue support successfully. Patient outcome: the patient was reported to be critical and was transferred to an outside hospital. Patient's height: (b)(6). There were no reports of patient complication or serious injury and death. There was a report of delay in therapy while inserting a second iab.
 
Manufacturer Narrative
(b)(4). The reported complaint of blood in helium pathway is confirmed. Our investigation determined that the iab bladder had a full thickness abrasion, which allowed blood to enter the iab. The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall. The root cause of the complaint is determined to be repeated contact with calcified plaque on the aortic wall. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. Unrelated to the reported complaint, during our investigation, the iab device returned to teleflex was found withdrawn through the teflon sheath. The instructions for use (ifu) states "do not remove arrow iab through hemostasis sheath introducer or hemostasis device. Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage. " due to this finding, an in-service will be performed to reiterate the correct method for iab removal to the customer.
 
Event Description
It was reported the event occurred in the cardiovascular intensive care unit (cvicu), the patient was being supported with the intra-aortic balloon pump (iabp). The physician stated that the intra-aortic balloon (iab) had ruptured after insertion and after the patient was transferred to the cvicu. The pump alarmed "possible helium loss" and blood was noted in the helium driveline. As a result the physician removed the iab and was replaced with a second iab to continue support successfully. Patient outcome: the patient was reported to be critical and was transferred to an outside hospital. Patient's height: 160cm. There were no reports of patient complication or serious injury and death. There was a report of delay in therapy while inserting a second iab.
 
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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 Key7318911
MDR Text Key101855057
Report Number3010532612-2018-00040
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 02/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F17D0026
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2017
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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