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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-R950-U
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504); Material Rupture (1546)
Patient Problems Venipuncture (2129); Injury (2348); Needle Stick/Puncture (2462)
Event Date 07/23/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: ve device (vad) implant qn# (b)(4). Other remarks: see mdr# 3010532612-2019-00276 ((b)(4)) as the report is related to the same patient.
 
Event Description
It was reported that the intra-aortic balloon (iab) was in use and the staff experience frequent helium loss alarms. The patient was repositioned, no blood was noted in the tubing, the helium and console changed, but the staff continued to receive the alarm. The patient was taken to the cath lab to remove the iab, and it was noted blood was in the tubing. As a result, the iab was removed and a new iab was used and inserted in the opposite leg. There was report of delay in therapy. There was no report of patient complication and death.
 
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Brand NameREDIGUARD IAB: 9FR 50CC
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
jonathan kimchan
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key8892404
MDR Text Key154247863
Report Number3010532612-2019-00273
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010330
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 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberIAB-R950-U
Device Lot Number18F18K0027
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 Received09/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2018
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: 08/14/2019 Patient Sequence Number: 1
Treatment
HOME DOBUTAMINESCHEDULED FOR VENTRICULAR ASSISTI
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