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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 SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problems Device Alarm System (1012); No Device Output (1435); Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after insertion of the intra-aortic balloon (iab), the staff noted they had no pressure waveform and were receiving high pressure alarms. The perfusionist had decreased the volume, but the pump continued to have alarms. As a result, the iab was removed and a second iab was inserted. The second iab was inserted without difficulty and is functioning appropriately. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of iab high pressure alarm is not confirmed. The returned iab was fully intact with no bends, kinks or damage noted. Although, the root cause of the complaint is undetermined the returned device passed visual and functional test specifications. No further action required at this time.
 
Event Description
It was reported that after insertion of the intra-aortic balloon (iab), the staff noted they had no pressure waveform and were receiving high pressure alarms. The perfusionist had decreased the volume, but the pump continued to have alarms. As a result, the iab was removed and a second iab was inserted. The second iab was inserted without difficulty and is functioning appropriately. There was no report of patient complication or serious injury and death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8264791
MDR Text Key133738242
Report Number3010532612-2018-00425
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17C0065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2019
Is This a Reprocessed and Reused Single-Use Device? No

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