MAUDE Adverse Event Report: AVINGER INCORPORATED PANTHERIS; CATHETER

Model Number A200

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Patient presented for elective aortogram with runoff, angioplasty and atherectomy of right sfa (superficial femoral artery) via left femoral access on (b)(6) 2016.During atherectomy, the physician noted difficulty removing the pantheris device over the filter wire (non-avinger device).Attempts to remove the pantheris device, filter wire, and ansel contralateral sheath (non-avinger device) were unsuccessful.It appears that the surgeon did not completely close the cutter of the pantheris device and pulled it into the sheath.As a result, the device caught on to the sheath.When he pulled the device out, the basket from the filter wire was determined to be still stuck.At this point, the physician decided to cut and clamp the wire with the plan to surgically remove the remaining portion of the wire and sheath.The patient was emergently brought to the operation room, a groin cut was made, and the remaining devices, including the basket of the filter wire, were surgically removed without complications.

• Brand Name: PANTHERIS
• Type of Device: CATHETER
• Manufacturer (Section D): AVINGER INCORPORATED; 400 chesapeake drive; redwood city 94063
• Manufacturer (Section G): AVINGER INCORPORATED; 400 chesapeake drive; redwood city 94063
• Manufacturer Contact: jennifer cleto ; 400 chesapeake drive; redwood city, CA 94063 ; 6502417900
• MDR Report Key: 5744867
• MDR Text Key: 48026592
• Report Number: 3007498664-2016-00008
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/18/2016
• Device Model Number: A200
• Device Catalogue Number: A200
• Device Lot Number: 160428007
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• 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: FILTER WIRE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR