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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 Fluid Leak (1250)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/13/2021
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that the catheter was placed during pci. The balloon worked for about 40 minutes, the (b)(6) nurse then found blood in the pressure tubing extension. When the balloon was removed, the catheter body broke. As a result, the catheter was removed, and another catheter was inserted at a different insertion site. There was no report of patient complications, patient condition was marked off as fine.
 
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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
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key12582971
MDR Text Key274931324
Report Number3010532612-2021-00271
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 09/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberIPN000257
Device Catalogue NumberIAB-06830-U
Device Lot Number18F19F0071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2019
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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