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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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INVATEC SPA PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date of event: approximate date.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during an attempt to use pacific xtreme device to treat a lesion in a patient, the physician noted a twist while inflating the balloon.This event occurred approximately 1-2 years ago.No patient injury or clinical sequelae reported or this event.
 
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Brand Name
PACIFIC XTREME
Type of Device
CATHETER, 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 Key5614191
MDR Text Key43839991
Report Number3004066202-2016-00144
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 03/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/30/2016
Initial Date FDA Received04/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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