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

Model Number	A400X
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Peripheral Vascular Disease (2002)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY, PRODUCT CODE: MCW
• Manufacturer (Section D): AVINGER INC.; 400 chesapeake drive; redwood city CA 94063
• MDR Report Key: 9418309
• Report Number: 3007498664-2019-00005
• Device Sequence Number: 1725274
• Product Code: MCW
• UDI-Device Identifier: 00851354004387
• UDI-Public: (01)00851354004387
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Weight: 90