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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
Model Number IPN000252
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that blood and condensation was noted in the gas drive tubing of the intra-aortic balloon (iab).The iab has been in for 4 days.As a result, the clinical support specialist (css) recommend removing the iab.There is no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is confirmed.Based on the customer pictures provided with the complaint report, blood is confirmed in the helium pathway.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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 and condensation was noted in the gas drive tubing of the intra-aortic balloon (iab).The iab has been in for 4 days.As a result, the clinical support specialist (css) recommend removing the iab.There is 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 Key10448961
MDR Text Key204220079
Report Number3010532612-2020-00235
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 08/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000252
Device Catalogue NumberIAB-05830-LWS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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