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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
Catalog Number IAB-06830-U
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem Blood Loss (2597)
Event Date 02/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). For reported complaint involving the same patient and device see mdr #3010532612-2019-00108 and (b)(4).
 
Event Description
It was reported that after intra-aortic balloon (iab) treatment, the sheath was removed successfully. The wall of the sheath was found damaged. The patient outcome was reported as fine. Additional information obtained. There was no report of removal difficulty during the sheath removal process. The sheath was found broken after finishing the treatment. It was also reported that the patient was injured. The patient lost much blood (about 200ml) as the un-smooth insertion. Additional information obtained. There were no adverse events from the blood loss. The patient did not require a blood transfusion, blood pressure did not decline and no reported increase in chest pain. There was no report of patient 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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key8497258
MDR Text Key141386597
Report Number3010532612-2019-00119
Device Sequence Number1
Product Code DSP
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberIAB-06830-U
Device Lot Number18F17M0006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2017
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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