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

Model Number A250

Device Problem Device Damaged by Another Device (2915)

Patient Problem Peripheral Vascular Disease (2002)

Event Date 02/07/2018

Event Type  Injury  

Event Description

During excision of tissue within the lumen of an indwelling vascular stent, it was reported that the pantheris catheter came in contact with the existing stent, and may have caused minor damage to the stent.Visualization of the stent in the oct image was reported to be clear prior to the engagement.After the pantheris device was freed from the stent struts, balloon angioplasty was performed on the stented region and a new stent was placed overlapping the existing stent as a precaution.This procedure was completed with no patient injury reported.No missing or detached components were reported.No malfunction of the pantheris catheter was reported.

• Brand Name: PANTHERIS
• Type of Device: PERIPHERAL, ATHERECTOMY, CATHETER
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: jay sundaram ; 400 chesapeake drive; redwood city, CA 94063
• MDR Report Key: 7270550
• MDR Text Key: 100064139
• Report Number: 3007498664-2018-00001
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152275
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/23/2018
• Device Model Number: A250
• Device Catalogue Number: A250
• Device Lot Number: 170523001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• 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: NITINOL STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 61