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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S730C
Device Problems Device Alarm System (1012); Fluid Leak (1250); Material Rupture (1546)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 08/17/2018
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted into the patient and later that night the staff had frequent "possible helium loss" alarms. The perfusionist was called to troubleshoot. There were no signs of blood in the tubing, or a kink and all the connections were tight. The alarm stopped. During the morning, the staff again experience "possible helium loss" alarm. At this time it was noticed there was a slight amount of blood in the gas drive tubing. As a result, the cardiologist was notified and the iab was removed with difficulty. The patient was sent to the operating room (or) for removal. A second iab was inserted on the right femoral artery. The vascular surgeon had to cut the iab to get the iab out. A clot was noted in the balloon. There was a report of patient's death after returning to the intensive care unit.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "blood in helium pathway" is not able to be confirmed. The product was not returned for investigation. The root cause of the complaint is undetermined. The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings. All devices passed manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted into the patient and later that night the staff had frequent "possible helium loss" alarms. The perfusionist was called to troubleshoot. There were no signs of blood in the tubing, or a kink and all the connections were tight. The alarm stopped. During the morning, the staff again experience "possible helium loss" alarm. At this time it was noticed there was a slight amount of blood in the gas drive tubing. As a result, the cardiologist was notified and the iab was removed with difficulty. The patient was sent to the operating room (or) for removal. A second iab was inserted on the right femoral artery. The vascular surgeon had to cut the iab to get the iab out. A clot was noted in the balloon. There was a report of patient's death after returning to the intensive care unit.
 
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Brand NameREDIGUARD IAB: 7FR 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 Key7873585
MDR Text Key120158662
Report Number3010532612-2018-00285
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981660
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 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIAB-S730C
Device Lot NumberUNKNOWN
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 Received10/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/13/2018 Patient Sequence Number: 1
Treatment
(B)(4)
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