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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problem Difficult to Advance (2920)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion, the physician was unable to insert the intra-aortic balloon (iab) catheter through the sheath. As a result, another iab catheter was used. There was a report of delay in therapy. It was reported by the physician that a second femoral puncture was done on the opposite groin. There was no report of death.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint that "unable to insert the balloon catheter through the sheath" is not able to be confirmed. Upon return, the supplied teflon sheath was noted on the bladder. Upon functional testing, the teflon sheath was able to be moved towards the bifurcate without any difficulty. The balloon membrane was fully intact with no abnormalities noted. The returned device passed visual and functional test specifications. The root cause of the complaint is undetermined. No further action required at this time.
 
Event Description
It was reported that during insertion, the physician was unable to insert the intra-aortic balloon (iab) catheter through the sheath. As a result, another iab catheter was used. There was a report of delay in therapy. It was reported by the physician that a second femoral puncture was done on the opposite groin. There was no report of death.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9109093
MDR Text Key159767704
Report Number3010532612-2019-00328
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,distri
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberIAB-06840-U
Device Lot Number18F17M0038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device? No

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