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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-U
Device Problem Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). For related complaint see mdr #3010532612-2018-00182 and tc (b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted and the doctor was unable to get the blood to return through the central lumen. As a result, another iab was used. Patient condition was reported as fine. There was no reported patient injury or clinical consequence.
 
Manufacturer Narrative
(b)(4). For related complaint see mdr #3010532612-2018-00182 and tc #(b)(4). Teleflex received the device for investigation. The reported complaint of central lumen occluded is confirmed. Upon aspiration and flushing, blood exited the central lumen but the test was successfully completed. The blood built up in the central lumen may have occurred from not maintaining a patency of the arterial line. The root cause of the complaint is undetermined. 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. This will be monitored for any developing trends. No further action required at this time. Other remarks:.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted and the doctor was unable to get the blood to return through the central lumen. As a result, another iab was used. Patient condition was reported as fine. There was no reported patient injury or clinical consequence.
 
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Brand NameULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7634301
MDR Text Key112214621
Report Number3010532612-2018-00179
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberIAB-05840-U
Device Lot Number18F17B0018
Other Device ID Number00801902010759
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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