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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 Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted through the right femoral artery after pci. The staff noted that it was found blocked and could not pass through the iliac artery. Repeated attempts were made, but the iab could not be advanced. After replacing the spring wire-guide (swg), the iab was still unable to pass through the iliac artery. As a result, a new iab kit was used and was able to advance into the right site smoothly. 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 Key9985668
MDR Text Key188536726
Report Number3010532612-2020-00110
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902003751
UDI-Public00801902003751
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 04/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberIPN000257
Device Catalogue NumberIAB-06830-U
Device Lot Number18F19K0070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2019
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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