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

Model Number A400X

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem Peripheral Vascular Disease (2002)

Event Date 11/14/2019

Event Type  malfunction  

Event Description

During atherectomy in the popliteal artery, the pantheris catheter contacted an indwelling vascular stent and resisted retraction.The physician gained pedal access, advanced a balloon retrograde and performed angioplasty to free the catheter from the stent.The procedure was completed with no patient injury reported.The device was successfully retrieved, and no missing or detached components of the device were confirmed.The ifu of the pantheris device instructs users how to identify the struts of an indwelling vascular stent using the real-time oct imaging component of the pantheris system in order to avoid such contact.

• Brand Name: PANTHERIS
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY, PRODUCT CODE: MCW
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• Manufacturer Contact: jay sundaram ; 400 chesapeake drive; redwood city, CA 94063 ; 6502417900
• MDR Report Key: 9418309
• MDR Text Key: 183163475
• Report Number: 3007498664-2019-00005
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00851354004387
• UDI-Public: (01)00851354004387
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/10/2021
• Device Model Number: A400X
• Device Catalogue Number: A400X
• Device Lot Number: 191002005
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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): Other
• Patient Age: 74 YR
• Patient Weight: 90