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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05830-U
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn that there is a bloody, frothy looking condensate in the helium drive line tubing, the nurse stated that he has not had any alarms.The clinical support specialist explained to the rn that the intra-aortic balloon (iab) had to be removed as soon as possible.The rn reported that the message would be related to the md.There was no report of patient injury or consequence.
 
Manufacturer Narrative
Qn#: (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 a broken central lumen and damaged outer lumen.Additionally, the iab bladder had a full thickness abrasion.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.It cannot be confidently determined which damage occurred first.The root cause of how the blood entered the helium pathway 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 by the rn that there is a bloody, frothy looking condensate in the helium drive line tubing, the nurse stated that he has not had any alarms.The clinical support specialist explained to the rn that the intra-aortic balloon (iab) had to be removed as soon as possible.The rn reported that the message would be related to the md.There was no report of patient injury or consequence.
 
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Brand Name
ULTRA 8 IAB: 8FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9410840
MDR Text Key169090530
Report Number3010532612-2019-00423
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902010742
UDI-Public00801902010742
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,health
Type of Report Initial,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Catalogue NumberIAB-05830-U
Device Lot Number18F19A0048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Date Manufacturer Received01/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXTRACORPOREAL MEMBRANE OXYGENATION.; EXTRACORPOREAL MEMBRANE OXYGENATION.; EXTRACORPOREAL MEMBRANE OXYGENATION.
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