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

Catalog Number	PCU060300130
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.Two twisted area was noted on the balloon 6 cm, and 15 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 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.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via dell'artigianato 25; torbole casaglia,bs ; IT
• MDR Report Key: 6787716
• Report Number: 3004066202-2017-00090
• Device Sequence Number: 101198
• Product Code: LIT
• UDI-Device Identifier: 08033477058283
• UDI-Public: 08033477058283
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: PCU060300130
• Device Lot Number: 213152306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1