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

Model Number A140-SV

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Event Description

During an atherectomy of the posterior tibial and peroneal artery, the guidewire lumen separated from the nosecone while advancing the device against resistance. The guidewire lumen was found on the guidewire when the device and guidewire were removed in its entirety from the patient. The procedure was completed with no reports of patient injury or harm. The ifu for this device states a precaution to determine the cause of resistance to movement of the catheter before proceeding with manipulation of the device.

• Brand Name: PANTHERIS SV
• 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: 9234834
• MDR Text Key: 183166343
• Report Number: 3007498664-2019-00003
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182341
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/04/2020
• Device Model Number: A140-SV
• Device Catalogue Number: A140-SV
• Device Lot Number: 190904001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/24/2019 Patient Sequence Number: 1