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

Catalog Number PCU060300130

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  

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.

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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via dell'artigianato 25; torbole casaglia,bs ; IT
• Manufacturer (Section G): INVATEC SPA; via dell'artigianato 25; torbole casaglia,bs ; IT
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6787716
• MDR Text Key: 82479814
• Report Number: 3004066202-2017-00090
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08033477058283
• UDI-Public: 08033477058283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1