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

Model Number A100

Device Problems Detachment Of Device Component (1104); Material Deformation (2976); Material Twisted/Bent (2981); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2017

Event Type  Injury  

Event Description

During an atherectomy of the superficial femoral artery, it was reported that the guidewire being used with the pantheris catheter wrapped around the distal portion of the catheter, causing resistance.When the catheter exited the insertion sheath its tip (nosecone including scaffold) was missing from the device.A fluoroscopic image was performed, and the tip was located inside the sheath, near the hemostasis valve.The sheath and pantheris catheter tip were removed from the patient.No part of the device was left inside the patient.The procedure was completed with no reports of serious patient injury.

• Brand Name: PANTHERIS
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• 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: 6772768
• MDR Text Key: 82006340
• Report Number: 3007498664-2017-00013
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163264
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/19/2017
• Device Model Number: A100
• Device Catalogue Number: A100
• Device Lot Number: 160419001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2016
• 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: 74 YR
• Patient Weight: 113