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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 Fluid Leak (1250); Off-Label Use (1494); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted via the subclavian artery (off-label use). The pump alarmed for helium loss and the iab had ruptured. The iab was removed and a new iab was inserted. The instructions for use (ifu) recommended site of insertion of an iab is the common femoral artery. There was a report of delay in therapy. There was no report of patient complications, serious injury or death.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted via the subclavian artery (off-label use). The pump alarmed for helium loss and the iab had ruptured. The iab was removed and a new iab was inserted. The instructions for use (ifu) recommended site of insertion of an iab is the common femoral artery. There was a report of delay in therapy. There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of iab blood in helium pathway is confirmed based on visual inspection of the device. The cause of the complaint was unable to be determined due to the returned state of the device. The iab was returned with numerous central lumen breaks and additional damage. During the investigation of the reported complaint, blood was found within the helium pathway. The root cause of how the blood entered the helium pathway is undetermined. Additionally, it was reported that the intra-aortic balloon (iab) was inserted via the subclavian artery (off-label use). The pump alarmed for helium loss due to an iab leak. The iab was removed and a new iab was inserted. The instructions for use (ifu) recommended site of insertion of an iab is the common femoral artery. 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 risk. This will be monitored for any developing trends. No further action required at this time.
 
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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 Key8695349
MDR Text Key147885022
Report Number3010532612-2019-00177
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 05/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F18E0022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No

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