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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problems Complete Blockage (1094); No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the central lumen on the intra-aortic balloon (iab) clotted.The rn reported that the arterial pressure (ap) waveform on the pump went totally flat.The rn tried to aspirate from the central lumen but was not able to draw anything back at all.As a result, the central lumen was capped off and they connected the transducer to the sidearm of the sheath.It was also recommended by the clinical support specialist (css) that a radial arterial line be placed to use for the ap source.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab central lumen occluded is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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 the central lumen on the intra-aortic balloon (iab) clotted.The rn reported that the arterial pressure (ap) waveform on the pump went totally flat.The rn tried to aspirate from the central lumen but was not able to draw anything back at all.As a result, the central lumen was capped off and they connected the transducer to the sidearm of the sheath.It was also recommended by the clinical support specialist (css) that a radial arterial line be placed to use for the ap source.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
 
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Brand Name
ULTRA 8 IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8656297
MDR Text Key146635497
Report Number3010532612-2019-00160
Device Sequence Number1
Product Code DSP
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 05/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue NumberIAB-06840-U
Device Lot Number18F18K0062
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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