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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 Entrapment of Device (1212)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 12/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the cardiac cath lab manager that upon removal of the intra-aortic balloon (iab), entrapment was discovered upon removal. The iab was "stuck" in the leg and vascular surgery was consulted for removal. The catheter was removed without further complications. It was described as a "knot on the central shaft of the balloon itself". The patient was stable and did not require iab support. The iab required surgical removal by a vascular surgeon. There was no report of patient 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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key9559220
MDR Text Key173967408
Report Number3010532612-2019-00466
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2021
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F19K0026
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/07/2020 Patient Sequence Number: 1
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