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U.S. Department of Health and Human Services

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

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INVATEC SPA PACIFIC PLUS US CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PCP050060130
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/20/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a revascularization procedure one medtronic standard pta was used to treat the anastomosis. During another revascularization procedure one medtronic standard pta was used to treat the in cannulation zone. Approx 10 months post first revascularization and three months post second revascularization, the patient suffered respiratory failure and died three days later. The investigator and safety assessed the event as not related to the index device, procedure or paclitaxel.
 
Manufacturer Narrative
The patient has a medical history of hypertension, hyperlipidemia, renal insufficiency, coronary heart disease and a previous peripheral revasc of the venous outflow. During the revasc to treat the anastomosis one pacific plus pta was used. During the revasc treat the in cannulation zone one inpact admiral pta was used. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Cec adjudicated event is not related to procedure, therapy or device. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePACIFIC PLUS US
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 Key8325274
MDR Text Key135698545
Report Number9612164-2019-00475
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123358
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
Report Date 05/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/19/2018
Device Catalogue NumberPCP050060130
Device Lot Number1G004905
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 Received04/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/20/2015
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: 02/11/2019 Patient Sequence Number: 1
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