MAUDE Adverse Event Report: AVINGER INC. OCELOT PIXL; PERCUTANEOUS CATHETER

Model Number P135

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Intimal Dissection (1333)

Event Date 01/23/2017

Event Type  malfunction  

Event Description

The physician was advancing an ocelot pixl catheter down the sfa (superficial femoral artery).The distal tip of the catheter got stuck at the distal cap of the chronic total occlusion.The catheter was forcefully retrieved.An angiogram revealed a small vessel dissection where the catheter was stuck.The physician performed a balloon angioplasty to tamponade the vessel dissection.There was no other adverse sequelae to the patient, and no further intervention was required.

• Brand Name: OCELOT PIXL
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer (Section G): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: jennifer cleto ; 400 chesapeake drive; redwood city, CA 94063 ; 6502417046
• MDR Report Key: 6313366
• MDR Text Key: 66863910
• Report Number: 3007498664-2017-00001
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: P135
• Device Catalogue Number: P135
• Device Lot Number: 160927005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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: 0.014" SPARTACORE GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR