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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problem Difficult to Flush (1251)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was unable to aspirate from the port. Therefore the iab was replaced by another device. There was no report of patient death, serious injury or complications.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of iab "unable to aspirate from the port" is not confirmed. Upon return, no damage or abnormalities were noted to the central lumen during visual inspection and functional testing. Although, the root cause of the complaint has remained undetermined the device passed visual and functional test specifications in relation to the reported complaint. 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. The reported complaint will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon (iab) was unable to aspirate from the port. Therefore the iab was replaced by another device. There was no report of patient death, serious injury or complications.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8196193
MDR Text Key131479373
Report Number3010532612-2018-00395
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902034724
UDI-Public00801902034724
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 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F17D0026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2019
Is This a Reprocessed and Reused Single-Use Device? No

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