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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. INTRA-AORTIC BALLOON CATHETER KIT

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ARROW INTERNATIONAL INC. INTRA-AORTIC BALLOON CATHETER KIT Back to Search Results
Catalog Number CARDIAC UNKNOWN
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported that the balloon burst from a previous patient. The presence of blood on the balloon connector and internal parts of the pump was found. Patient information is unknown at this time. There was no report of complication, serious injury, or death to the patient.
 
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Brand NameINTRA-AORTIC BALLOON CATHETER KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key12338908
MDR Text Key268541777
Report Number3010532612-2021-00251
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeFR
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 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2021
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 Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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