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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000252
Device Problems Fluid Leak (1250); Off-Label Use (1494); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). See mdr #3010532612-2019-00457 and (b)(4) for complaint involving the same patient and event.
 
Event Description
It was reported by the rn that blood was noted in the driveline tubing. The rn called the hotline and spoke to the clinical support specialist (css) and reported that there was blood in the current tubing. The patient was received from an outside hospital. The css explained that the blood in the tubing meant that there was a balloon rupture and the balloon needed to be removed. The rn stated that the physicians did not want to change out the intra-aortic balloon (iab). The iab was not inserted through the femoral artery. The css explained the possible complications if they continue to use the iab. The nurse stated that she would contact the physician. The css received another call from the facility, this time it was the fellow. He wanted assistance in switching the gas drive line tubing over to the maquet intra-aortic balloon pump (iabp). The css discussed with the dr. That if the iab was left in place that it could result in difficulties with removal and complications to the patient. The dr. Is aware of the possible complications to the patient but did not want to change out the catheter. The css explained how to change the gas drive tubing to the maquet pump. The iab was inserted off label. There was no report of injury or consequence to the patient.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key9526880
MDR Text Key183768271
Report Number3010532612-2019-00455
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 12/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberIPN000252
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F18L0001
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 Received01/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
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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