MAUDE Adverse Event Report: AVINGER INC. PANTHERIS; CATHETER

Model Number A250

Device Problem Device Damaged by Another Device (2915)

Patient Problem Peripheral Vascular Disease (2002)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

Device was discarded and not returned.

Event Description

During an atherectomy, it was reported that the pantheris catheter caught the struts of an existing stent in the distal superficial femoral artery and became stuck.The stent struts did not break off or become detached.At this time, the physician decided to gain antegrade access and perform balloon angioplasty to free the catheter from the stent.The area where the catheter was stuck was re-stented, and the procedure was completed with no patient injury reported.

• Brand Name: PANTHERIS
• Type of Device: 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: 6324490
• MDR Text Key: 67205668
• Report Number: 3007498664-2017-00002
• Device Sequence Number: 1
• Product Code: MCW
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/18/2018
• Device Model Number: A250
• Device Catalogue Number: A250
• Device Lot Number: 161118004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR