MAUDE Adverse Event Report: AVINGER INCORPORATED AVINGER WILDCAT 5F CATHETER (KITTYCAT II); PERCUTANEOUS CATHETER

Model Number W550

Device Problem Material Fragmentation (1261)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

Device not manufactured by reporting firm) the 0.018" asahi treasure 12 guidewire is not manufactured by avinger.

Event Description

The patient presented for revascularization of a heavily calcified superficial artery.A kittycat ii (w550) was used over an 0.018" asahi treasure 12 wire in the sfa cto.Dr (b)(6) explained that when trying to traverse the catheter over the wire in the proximal sfa cto, the guidewire became lodged within the kittycat ii and was not able to be removed.In order to facilitate removal the kittycat ii and guidewire had to be withdrawn from the site as a unit.When removing the guidewire and the kittycat ii, a fragment of the guidewire broke off in the sfa.Once the kittycat ii and 0.018" guidewire were removed, dr.(b)(6) used a different device, a wildcat (w400) and successfully crossed the sfa cto.Dr.(b)(6) then safely stented the area where the fragment of the guidewire had been left behind.

• Brand Name: AVINGER WILDCAT 5F CATHETER (KITTYCAT II)
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): AVINGER INCORPORATED; 400 chesapeake drive; redwood city CA 94063
• Manufacturer (Section G): AVINGER INCORPORATED; 400 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: jennifer cleto ; 400 chesapeake drive; redwood city, CA 94063 ; 6502417900
• MDR Report Key: 5700638
• MDR Text Key: 46619729
• Report Number: 3007498664-2016-00001
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: W550
• Device Catalogue Number: W550
• Device Lot Number: 150730002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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
• Treatment: 018 TREASURE 12 ASAHI GUIDEWIRE
• Patient Outcome(s): Required Intervention