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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); Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use, it was noted by the staff that the catheter was obstructed, and the pump alarmed showing no pressure signal. As a result, the catheter was removed, and another attempt was performed with a new catheter successfully. Patient outcome reported as fine. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). A preliminary investigation was done and the returned iab was noted unused and was not removed from the original packaging tray. The returned device was not used on the patient therefore the complaint does not correlate with the reported event details. This complaint has been changed to a not reportable complaint.
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use, it was noted by the staff that the catheter was obstructed, and the pump alarmed showing no pressure signal. As a result, the catheter was removed, and another attempt was performed with a new catheter successfully. Patient outcome reported as fine. There was no report of patient complication or serious injury and death.
 
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Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8169512
MDR Text Key130503068
Report Number3010532612-2018-00384
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue NumberIAB-S730C
Device Lot Number18F17K0051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

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