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U.S. Department of Health and Human Services

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

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INVATEC SPA PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Thrombus (2101)
Event Date 11/25/2017
Event Type  Injury  
Manufacturer Narrative

Published date viabahn stent for hemodialysis shunt: efficacy, long segment recanalization and prognostic factors for reintervention the journal of vascular access 2018, vol. 19(1) 76¿83 © the author(s) 2017 reprints and permissions: sagepub. Co. Uk/journalspermissions. Nav doi: 10. 5301/jva. 5000823 journals. Sagepub. Com/home/jva. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The study evaluated the heparin bioactive surface (hbs) non-medtronic device efficacy in the maintenance or re-establishment of hemodialysis. Outcomes were stent patency intended as primary circuit patency (pp), assisted primary patency (app), target lesion primary patency (tlpp) and secondary patency (sp). Once the lesion had been crossed, pre-dilatation with 2- or 3-mm diameter balloon catheter (pacific plus, medtronic, (b)(4)) was subsequently performed to allow the passage of the delivery system. If the obstruction segment was crossed by 0. 014¿ guidewire, it was replaced by 0. 018¿ guidewire. The 4 fr short introducer sheath was then changed for a short introducer sheath with profile ranged from 6 fr to 8 fr, depending on stent diameter that was selected according to the diameter of the adjacent normal reference vessel. If the lesion could not be crossed, a second retrograde access was required through the puncture of the venous outflow, slightly more proximal to the obstruction. It is reported that 37 patients underwent 50 stent graft placement. Repeat procedures were required in cases where hemodialysis access dysfunction was identified with a total of 88 repeat procedures being undertaken. Three complications occurred: minor complications included two access hematoma that were conservatively managed with no consequences on hemodialysis circuit. A single case of infection of avg by staphylococcus aureus occurred three months after the stent placement. One procedure was unsuccessful because the circuit thrombosis occurred two days after the stent placement and the hemodialysis access was abandoned.

 
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Brand NamePACIFIC PLUS
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta 7
roncadelle (bs) 25030
IT 25030
Manufacturer (Section G)
INVATEC SPA
via martiri della liberta 7
roncadelle (bs) 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key8051406
MDR Text Key126546944
Report Number3004066202-2018-00053
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received10/15/2018
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

Patient TREATMENT DATA
Date Received: 11/08/2018 Patient Sequence Number: 1
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