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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000260
Device Problems Fluid Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that blood was found in the helium driveline tubing of the intra-aortic balloon (iab) during use on a patient. As a result, a new catheter was used. 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 the helium pathway is confirmed. A break in the central lumen was noted near the proximal end of the iab catheter, which can cause blood to enter the helium pathway. Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray. This damage indicates the iabc was not prepped correctly per the ifu and can result in damage to the iabc. An in-service has been requested to reiterate the instructions for use (ifu), including the appropriate method for iabc prep/removal from its packaging. The root cause of the broken central lumen is undetermined, but a potential cause is customer handling. 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 revived risk. This will be monitored for any developing trends.
 
Event Description
It was reported that blood was found in the helium driveline tubing of the intra-aortic balloon (iab) during use on a patient. As a result, a new catheter was used. There was no report of patient complications, serious injury or death.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9858724
MDR Text Key184472660
Report Number3010532612-2020-00063
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,distri
Type of Report Initial,Followup,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberIPN000260
Device Catalogue NumberIAB-06840-U
Device Lot Number18F18D0024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No

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