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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA REEF HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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INVATEC SPA REEF HP CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number REU060040082
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/14/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician intended to use a reef pta balloon to treat an intravenous fistula. There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop. The device was not prepped per ifu. The device was inflated with a non medtronic device. The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device to the fistula. It was reported that, during the procedure, when the balloon pressure was 20, the front of the balloon became disconnected. Upon applying further pressure, the balloon did not maintain inflation. When the balloon was removed, it was found that some of it had become detached and some remained in the patient vasculature. Post procedure, a surgical cut down was required to retrieve the detached portion of the balloon.
 
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Brand NameREEF HP
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer (Section G)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8711350
MDR Text Key148401626
Report Number3004066202-2019-00027
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/06/2020
Device Catalogue NumberREU060040082
Device Lot Number1I002692
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 Received06/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/07/2017
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: 06/19/2019 Patient Sequence Number: 1
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