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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000257
Device Problems Material Puncture/Hole (1504); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use it was noted that the balloon leak after implant and the staff received a helium loss alarm from the intra-aortic balloon pump (iabp). As a result, a new iab was used and inserted using the same insertion site. There was no report of patient complications, serious injury or death.
 
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Brand NameULTRAFLEX IAB: 7.5FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key10642738
MDR Text Key210241554
Report Number3010532612-2020-00289
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model NumberIPN000257
Device Catalogue NumberIAB-06830-U
Device Lot Number18F18C0033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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