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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC.

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ARROW INTERNATIONAL INC. Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problem Unraveled Material (1664)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Other remarks: see mdr# 3010532612-2020-00036 and (b)(4) as the report is related to the same patient.
 
Event Description
It was reported that the intra-aortic balloon (iab) unraveled upon insertion. As a result, another iab was used via the same insertion site on the right femoral. There was no report of patient complications, serious injury or death.
 
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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 Key9666996
MDR Text Key181978332
Report Number3010532612-2020-00037
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeAS
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 01/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCARDIAC UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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