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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 Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199)
Event Date 05/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).For related complaint involving the same patient and event see mdr #3010532612-2019-00189 and (b)(4).
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use it was noted by the perfusionist that within the first 30 minutes the balloon "broke".The iab ruptured in a heavy calcified aorta.As a result, a new iab was used.There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).For related complaint involving the same patient and event see mdr #3010532612-2019-00189 and (b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.The iab was confirmed with a leak from the outer lumen which allowed blood to enter the helium pathway.The leak site identified is consistent with contact from a sharp object.The root cause of the outer lumen leak is undetermined, but a potential cause of how the iab came into contact with a sharp object is due to 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 revised risk.This will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use it was noted by the perfusionist that within the first 30 minutes the balloon "broke".The iab ruptured in a heavy calcified aorta.As a result, a new iab was used.There was no report of patient injury or consequence.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8717591
MDR Text Key149567814
Report Number3010532612-2019-00190
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 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F17J0015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2019
Date Manufacturer Received07/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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