MAUDE Adverse Event Report: AVINGER INC. PANTHERIS; PERIPHERAL ATHERECTOMY CATHETER

Model Number A200

Device Problems Detachment Of Device Component (1104); Poor Quality Image (1408); Difficult to Remove (1528); Torn Material (3024)

Patient Problem Thromboembolism (2654)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

During atherectomy of an aneurysm in the sfa, a pantheris catheter and a 4 mm spiderwire embolic protection device became stuck in the lumen of the vascular sheath and could not be retracted.The surgeon attempted unsuccessfully for 90 minutes to remove the pantheris catheter and spiderwire before advancing a 7 fr guide catheter, which facilitated removal of both devices.After an extended time attempting to remove the two devices, it was noted that the patient's profunda and vessels below the knee shut down, but blood flow was restored successfully by the surgeon.Upon removal, the nosecone of the pantheris catheter was noticed to be missing.A ct scan located the nosecone near the entry site of the indwelling catheter, and it was removed from the patient's body without complications.The patient was released the next morning and reported to be doing fine.

• Brand Name: PANTHERIS
• Type of Device: PERIPHERAL ATHERECTOMY 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: bunty banerjee ; 400 chesapeake drive; redwood city, CA 94063 ; 8002082988
• MDR Report Key: 6664719
• MDR Text Key: 78382157
• Report Number: 3007498664-2017-00010
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/09/2017
• Device Model Number: A200
• Device Catalogue Number: A200
• Device Lot Number: 160309039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR