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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000254
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that the balloon ruptured. The patient had been on their back and moving their arms around. The nurse noted blood filling up in the gas tubing. About 5 minutes after the blood was noted, the pump gave a "possible helium loss" alarm. It was noted that there had been no other issues with the balloon or pump prior to the blood in the gas tubing. It is possible that blood got into the pump. There is no blood in the condensation bottle. The pump will be sent to biomed to be inspected. As a result, the balloon was removed, and the patient was stable without the iab. There was no report of delay in therapy. There was no report of patient complication, serious injury, or death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key12720392
MDR Text Key279057373
Report Number3010532612-2021-00359
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F21D0026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2021
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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