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U.S. Department of Health and Human Services

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

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INVATEC SPA REEF CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNK-CV-GWY-REEF
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/29/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure the left anastomosis was pre-dilated with a medtronic balloon and treated with a medtronic standard pta balloon catheter. Approximately 9 months post index procedure, patient suffered a high grade stenosis of the avf in the juxta anastomotic region. The patient was treated with medication and a non medtronic pta in the anastomosis. The investigator assessed this event as not related to the index device, procedure or paclitaxel. The event is resolved.
 
Manufacturer Narrative
During the index procedure a reef balloon catheter was used to treat the anastomosis. Safety assessed the event as not related to the index device, procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The anastomosis was further treated with a non-mdt pta. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Cec adjudicated event as not related to procedure or therapy but related to device. Revascularization is clinically driven. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameREEF
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 Key7634152
MDR Text Key112188668
Report Number9612164-2018-01530
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-REEF
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 Received10/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 06/25/2018 Patient Sequence Number: 1
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