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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
Catalog Number PCU050200130
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: the device was returned the original box. The data on the luer was consistent with lot number indicated in the product complaint form. Visual and tactile inspections were performed. No damages have been noted on the shaft. The balloon was used. A twisted area was noted on the balloon 11 cm from the tip. It was not possible to insert the 0,018¿¿ guide wire because there was hardened blood inside the guidewire lumen. The purging procedure was performed with no issues. The balloon was inflated at 2 bar and its profile resulted deformed in the point of twisting. At 14 bar it was also possible to note a deformation point on the guide wire tube just below the wrinkled area, identified as point of twist. No further issues found. Additional information received: the devices were moved and repositioned during the procedure but the twists did not go away. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician used two pacific xtreme devices to treat a lesion located in the sfa. The device was removed from its packaging prepped per the ifu and inspected before use with no issues noted. Embolic protection was not used and a non-mdt inflation device was used. The balloons did not pass through a previously deployed stent. It was reported that excessive force was not used when advancing the devices. It was reported that both balloons were twisted. No rewrap tool was used and no rewrap issues were noted. The physician continued with the devices and completed the procedure successfully. No patient injury was reported.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
INVATEC SPA
via martiri della liberta
roncadelle,bs 25030
IT 25030
Manufacturer (Section G)
INVATEC SPA
via martiri della liberta
roncadelle,bs 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6787719
MDR Text Key113791921
Report Number3004066202-2017-00089
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 09/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberPCU050200130
Device Lot Number213181225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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