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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); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during use on a patient, the intra-aortic balloon pump (iabp) received a high pressure alarm. It was noted that on the intra-aortic balloon (iab) there was blood in the line. As a result, the iab was removed and another attempt was successfully made with a new iab. 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. A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the iab which allowed blood to enter the helium pathway. No other leaks were detected during functional testing. The root cause of the broken fiber 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.
 
Event Description
It was reported that during use on a patient, the intra-aortic balloon pump (iabp) received a high pressure alarm. It was noted that on the intra-aortic balloon (iab) there was blood in the line. As a result, the iab was removed and another attempt was successfully made with a new iab. There was no report of patient complications, serious injury or 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 Key9260988
MDR Text Key183740750
Report Number3010532612-2019-00386
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,foreig
Type of Report Initial,Followup
Report Date 10/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17L0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No

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